N/A 309597Recalls & reported problems

Summary

The FDA's MAUDE database contains 92 adverse event reports that list this exact device (DI 00382903095971), received between Feb 6, 2018 and Nov 6, 2024 — classified as 1 injury, 91 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (36 reports).

10 other recalls cover devices cleared under the same FDA submission (K110771); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 92 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 6, 2024Defective Component; Defective Component

  MATERIAL: 309597, BATCH#: UNKNOWN. IT WAS REPORTED THAT THE BD SYRINGE 1ML S/T W/NDL 26X5/8 RB PLUNGER ROD WAS BROKEN / DAMAGED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: RCC RECEIVED A COMPLAINT VIA EMAIL. PLUNGER HAS FALLEN THROUGH BEFORE, LOSING A BIT OF PRODUCT. HAS ALSO HAD BENT NEEDLES IN THE PAST. BD SYRINGE LOT NUMBER(S): LOT: UNKNOWN BD PART NUMBER: 309623 OR 309597.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20621397 ↗
• MalfunctionJul 11, 2024Separation Problem; Separation Problem

  MATERIALS#: 309597. BATCH#: 2263232. IT WAS REPORTED BY THE CUSTOMER THAT NEEDLES ARE DULL AND COME OFF SYRINGE WHEN TRYING TO INJECT MEDICATION. NEEDLES BLOW OFF AND MEDICATION LEAKS OUT CAUSING PATIENT TO REATTACH NEEDLE AND ATTEMPT TO INJECT DOSE AGAIN. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. NOTIFICATION ONLY FOR PR# 4308226 ¿ NEEDLE - BLUNT/DULL. BD SYRINGE: PLASTIC DOSING SYRINGE (1 ML) WITH NEEDLE ATTACHED (26G, 5/8 INCH). BD SYRINGE LOT NUMBER(S): 2263232. TAKEDA AWARENESS DATE: 16 MAY 2024. PATIENT REPORTS ISSUES WITH INJECTION SYRINGE AND GETTING FULL DOSE FROM VIAL. NEEDLES ARE DULL AND COME OFF SYRINGE WHEN TRYING TO INJECT MEDICATION. NEEDLES BLOW OFF AND MEDICATION LEAKS OUT CAUSING PATIENT TO REATTACH NEEDLE AND ATTEMPT TO INJECT DOSE AGAIN. PRODUCT: GATTEX . COUNTRY OF ORIGIN: UNITED STATES. SAMPLE / PHOTO AVAILABILITY: NO SAMPLE OR PHOTOS WERE PROVIDED TO TAKEDA. AE: NO AE REPORTED . PATIENT IDENTIFIERS AVAILABLE? (I.E. GENDER, WEIGHT, ETHNICITY, ETC.): PATIENT IDENTIFIERS WILL NOT BE AVAILABLE FOR ANY INVESTIGATION REQUEST.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19724775 ↗
• MalfunctionJun 10, 2024Complete Blockage; Complete Blockage

  MATERIALS#: 309597 BATCH#: 2263232. IT WAS REPORTED THAT THE BD SYRINGE 1ML S/T W/NDL 26X5/8 RB WAS CLOGGED/BLOCKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "FOR THE LAST 2 DAYS PATIENT'S 27 GAUGE NEEDLE HAS BEEN COMING OFF WHEN HE PUSHED PLUNGER TO ADMINISTER MEDICATION." VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. EXTERNAL EVALUATION IS REQUIRED FOR TAKEDA TW PR# (B)(4) ¿ NEEDLE BENT/BROKEN/DAMAGED PRODUCT: GATTEX BD PLASTIC DOSING SYRINGE (1 ML) WITH NEEDLE ATTACHED (26G, 5/8 INCH)). BD SYRINGE LOT NUMBER(S): 2263232. TAKEDA AWARENESS DATE: 14 MAY 2024. COMPLAINT OWNER: DESCRIPTION: FOR THE LAST 2 DAYS PATIENT'S 27 GAUGE NEEDLE HAS BEEN COMING OFF WHEN HE PUSHED PLUNGER TO ADMINISTER MEDICATION. PATIENT'S HUSBAND INSISTED ON TROUBLESHOOTING ISSUE AND DECLINED PHARMACIST. STATUS: REQUESTING EXTERNAL EVALUATION: COUNTRY OF ORIGIN: UNITED STATES. SAMPLE / PHOTO AVAILABILITY: NO SAMPLE OR PHOTOS WERE PROVIDED TO TAKEDA. AE: NO AE REPORTED. PATIENT IDENTIFIERS AVAILABLE? (I.E. GENDER, WEIGHT, ETHNICITY, ETC.): PATIENT IDENTIFIERS WILL NOT BE AVAILABLE FOR ANY INVESTIGATION REQUEST. NO ADDITIONAL INFORMATION PROVIDED. INV DUE BY: 14JUNE2024

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19506796 ↗
• MalfunctionJun 4, 2024Leak/Splash; Leak/Splash

  MATERIAL# 309597 BATCH# 2263232. IT WAS REPORTED THAT THE BD INTEGRA LEAKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: AN EXTERNAL EVALUATION IS REQUIRED FOR TWO COMPLAINT DEFECT TYPES FROM ONE REPORTER: PR# (B)(4) - LEAKING. PR# (B)(4) - PRIMARY PACKAGING / CONTAINER DIFFICULT TO OPEN. BD SYRINGE: PLASTIC DOSING SYRINGE (1 ML) WITH NEEDLE ATTACHED (26G, 5/8 INCH). BD SYRINGE LOT NUMBERS: 2263232. TAKEDA AWARENESS DATE: 30 APR 2024. THE PATIENT STATED THAT THE NEEDLE CAME OFF YESTERDAY WHEN GIVING THE GATTEX AND HE HAD TO USE ANOTHER VIAL, SO HE WILL BE SHORT ONE VIAL THIS MONTH. THE PATIENT STATED THAT HE IS ALWAYS SHORT ONE VIAL OF DILUENT. NO ADDITIONAL INFORMATION PROVIDED. AFTER FOLLOWING UP WITH PATIENT, WHILE ON THE CALL. CUSTOMER CLAIMED THAT THE ISSUE WAS WITH LEAKING. DOSING SYRINGE SEPARATED UPON USE. CAUSING THE MEDICATION TO LEAK OUT ONTO PATIENT'S LEG. AN ADDITIONAL COMPLAINT WAS REPORTED. THE PATIENT IS CLAIMING THAT THE DOSING SYRINGES CAPS ARE DIFFICULT TO OPEN / REMOVE. PATIENT STRUGGLES AT THIS CAP REMOVAL. THE CAP TAKES A LOT OF PRESSURE TO REMOVE. CAPS CAN FLY ACROSS THE ROOM SOMETIMES; DUE TO THE AMOUNT OF PRESSURE AND FORCE IT TAKES TO O

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19459911 ↗
• MalfunctionMar 21, 2024Connection Problem; Connection Problem

  IT WAS REPORTED THAT THE BD INTEGRA SYRINGE HAD A NEEDLE CONNECTIVITY ISSUE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: EXTERNAL EVALUATION IS REQUIRED FOR TAKEDA TW (B)(4) - GATTEX - NEEDLE - BENT/ BROKEN/DAMAGED PRODUCT: GATTEX BD PLASTIC DOSING SYRINGE (1 ML) WITH NEEDLE ATTACHED (26G, 5/8 INCH) BD SYRINGE LOT NUMBER(S): 2263232 TAKEDA AWARENESS DATE: 21FEB2024. COMPLAINT OWNER: (B)(6) PPD PQC INTAKE RECEIVED A CALL ON (B)(6) 2024 AT 11:47AM: PHARMACIST CALLED AND STATED THAT PATIENT IS TAKING GATTEX 5MG VIAL AND REPORTED THAT IT IS LEAKING, THE NEEDLE IS LOOSE, AND HE IS HAVING DIFFICULTY WITH THE SYRINGES INCLUDED WITHIN THE KIT. THE CALLER ADVISED THIS HAS BEEN AN ONGOING ISSUE SO THERE IS NO SPECIFIC DATE. THE CALLER MENTIONED THE VIAL WAS LEAKING AND THE NEEDLE WAS LOOSE AND CAME OFF IN THE PATIENTS HAND. THE CALLER ALSO MENTIONED THAT THE PATIENT IS HAVING DIFFICULTY WITH THE SYRINGES THAT ARE INCLUDED WITHIN THE KIT HE IS DRAWING IN AIR WITH THE SYRINGES. THE CALLER ATTEMPTED TO CONTACT THE PATIENT WHO COULD NOT HOLD DUE TO TIME, THE CALLER MENTIONED IF SOMEONE CAN CALL HIM BACK LATER. RPH WAS PROVIDED THE NUMBER TO MEDICAL INFORMATION TO CALL BACK AT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18955790 ↗
• MalfunctionMar 6, 2024Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE BD INTEGRA LEAKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "NURSE EDUCATOR REPORTED THAT PATIENT REPORTED THAT UPON INITIAL ATTEMPT TO MIX MEDICATION, THE DILUENT SYRINGE TOP WAS OPEN, DROPS OF DILUENT WERE OBSERVED AT THE TIP OF THE NEEDLE, AND DILUENT WAS MISSING FROM THE PREFILLED SYRINGE. NURSE EDUCATOR REPORTED THAT PATIENT REPORTED THE COMPROMISED SYRINGE WAS DISCARDED AND A NEW PREFILLED SYRINGE WAS USED." EXTERNAL EVALUATION IS REQUIRED FOR TAKEDA TW PR# (B)(4) ¿ DEFECTIVE COMPONENT PRODUCT: GATTEX BD PLASTIC DOSING SYRINGE (1 ML) WITH NEEDLE ATTACHED (26G, 5/8 INCH) . BD SYRINGE LOT NUMBER(S): 2263811. TAKEDA AWARENESS DATE: 22 JAN 2024. COMPLAINT OWNER: (B)(6). DESCRIPTION: NURSE EDUCATOR REPORTED THAT PATIENT REPORTED THAT UPON INITIAL ATTEMPT TO MIX MEDICATION, THE DILUENT SYRINGE TOP WAS OPEN, DROPS OF DILUENT WERE OBSERVED AT THE TIP OF THE NEEDLE, AND DILUENT WAS MISSING FROM THE PREFILLED SYRINGE. NURSE EDUCATOR REPORTED THAT PATIENT REPORTED THE COMPROMISED SYRINGE WAS DISCARDED AND A NEW PREFILLED SYRINGE WAS USED. STATUS: REQUESTING EXTERNAL EVALUATION. COUNTRY OF ORIGIN: UNITED STATES. SAMPLE / PHOTO AVAILABILITY:

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18846982 ↗
• MalfunctionFeb 21, 2024Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT THE BD INTEGRA CONTAINED FOREIGN MATTER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "PATIENT'S HUSBAND STATES THAT THE INJECTION SYRINGES DON'T RELEASE MEDICATION EASILY WITHOUT BEING WIPED WITH AN ALCOHOL SWAB. HE HAS TO CLEAN THE TIP OF THE NEEDLE WITH AN ALCOHOL SWAB BEFORE DRAWING UP THE MEDICINE BECAUSE HE BELIEVES THERE IS DEBRIS OR SOMETHING ON THE TIP OF THE NEEDLE MAKING IT IMPOSSIBLE TO DRAW UP THE MEDICINE." A EXTERNAL EVALUATION IS REQUIRED FOR (B)(4) ¿ WITHDRAWING DIFFICULTY. BD SYRINGE: PLASTIC DOSING SYRINGE (1 ML) WITH NEEDLE ATTACHED (26G, 5/8 INCH). BD SYRINGE LOT NUMBERS: 2263811. (B)(4) AWARENESS DATE: 23 JAN 2024. PATIENT'S HUSBAND STATES THAT THE INJECTION SYRINGES DON'T RELEASE MEDICATION EASILY WITHOUT BEING WIPED WITH AN ALCOHOL SWAB. HE HAS TO CLEAN THE TIP OF THE NEEDLE WITH AN ALCOHOL SWAB BEFORE DRAWING UP THE MEDICINE BECAUSE HE BELIEVES THERE IS DEBRIS OR SOMETHING ON THE TIP OF THE NEEDLE MAKING IT IMPOSSIBLE TO DRAW UP THE MEDICINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18748177 ↗
• MalfunctionFeb 5, 2024Disconnection; Disconnection

  NO ADDITIONAL INFORMATION

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18646762 ↗
• MalfunctionFeb 5, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE BD INTEGRA SYRINGE NEEDLE PULLED OUT OF THE HUB. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "PATIENT HAS BEEN HAVING PROBLEMS WITH THE LAST TWO SHIPMENTS. ON THE FIRST SHIPMENT THE NEEDLE FELL OFF BEFORE SHE ADMINISTERED THE INJECTION. WITH THE SECOND RECENT SHIPMENT, THE NEEDLE DISCONNECTED FROM THE SYRINGE, AND SHE HAD TO PULL IT OUT OF HER STOMACH." EXTERNAL EVALUATION IS REQUIRED FOR TAKEDA TW PR# (B)(4) ¿- GATTEX - NEEDLE - BENT/BROKEN/DAMAGED PRODUCT: GATTEX BD PLASTIC DOSING SYRINGE (1 ML) WITH NEEDLE ATTACHED (26G, 5/8 INCH) BD SYRINGE LOT NUMBER(S): 2263232 TAKEDA AWARENESS DATE: 03JAN2024 REPORT RECEIVED FROM ACCREDO ON 03JAN2024 PATIENT HAS BEEN HAVING PROBLEMS WITH THE LAST TWO SHIPMENTS. ON THE FIRST SHIPMENT THE NEEDLE FELL OFF BEFORE SHE ADMINISTERED THE INJECTION. WITH THE SECOND RECENT SHIPMENT, THE NEEDLE DISCONNECTED FROM THE SYRINGE AND SHE HAD TO PULL IT OUT OF HER STOMACH. KIT LOTS:: AV23219AA, AV23116AA AND EXPIRATION DATES: 07/31/2024, 08/31/2024 STATUS: REQUESTING EXTERNAL EVALUATION SAMPLE / PHOTO AVAILABILITY: NO SAMPLE OR PHOTOS WERE PROVIDED TO TAKEDA. AE: AE UNKNOWN PATIENT IDENTIFIERS AVAILABLE? (I.E. GEND

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18646761 ↗
• MalfunctionJan 9, 2024Volume Accuracy Problem; Volume Accuracy Problem

  IT WAS REPORTED THAT THE BD INTEGRA SYRINGES HAD A SCALE MARKING ISSUE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "PATIENT REPORTED HE DID NOT GET THE SAME SYRINGES HE HAS BEEN RECEIVING. HE STATED THE OUTER PACKAGE IS THE SAME BUT THE SYRINGES DID NOT HAVE MARKINGS AND THEY ARE THINNER SYRINGES." RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. EXTERNAL EVALUATION IS REQUIRED FOR TAKEDA TW PR# 3905272 ¿ DEFECTIVE COMPONENT PRODUCT: GATTEX BD PLASTIC DOSING SYRINGE (1 ML) WITH NEEDLE ATTACHED (26G, 5/8 INCH) BD SYRINGE LOT NUMBER(S): 2263232. TAKEDA AWARENESS DATE: 07 NOV 2023. PATIENT REPORTED HE DID NOT GET THE SAME SYRINGES HE HAS BEEN RECEIVING. HE STATED THE OUTER PACKAGE IS THE SAME BUT THE SYRINGES DID NOT HAVE MARKINGS AND THEY ARE THINNER SYRINGES. SAMPLE / PHOTO AVAILABILITY: SAMPLE WAS NOT PROVIDED TO TAKEDA. NO PHOTOS PROVIDED. AE: N/A PATIENT IDENTIFIERS AVAILABLE? (I.E. GENDER, WEIGHT, ETHNICITY, ETC.): PATIENT IDENTIFIERS WILL NOT BE AVAILABLE FOR ANY INVESTIGATION REQUEST.

  Patient problems: Insufficient Information

  MAUDE report 18480475 ↗
• MalfunctionJan 2, 2024Break; Break

  ADDITIONAL INFORMATION RECEIVED: ANY ADVERSE EVENT OR SERIOUS INJURY REPORTED TO PATIENT OR HEALTHCARE PROFESSIONAL? NO. 2. WAS THERE A DELAY OF, OR CHANGE IN, THE COURSE OF TREATMENT DUE TO THE EVENT? NO. 3. ANY SAMPLE OR PHOTO AVAILABLE FOR INVESTIGATION? NO. 4. HOW WAS THE PATIENT OUTCOME? ARE THERE ANY CLINICAL SIGNS, HEALTH CONSEQUENCES OR IMPACT? NO. 5. HOW WAS TREATMENT COMPLETED FOR CUSTOMER? DID NOT SPECIFY. 6. PATIENT STATUS? DID NOT SPECIFY. 7. ANY PHOTOS OR VIDEOS IN NEEDLE BROKEN PART? NO. 8.COULD YOU KINDLY CONFIRM THE NEEDLE STICK INJURY OCCURRED ON THE PATIENT / HEALTH PROFESSIONAL? PATIENT. 9.HOW WAS TREATMENT COMPLETED FOR CUSTOMER? DID NOT SPECIFY. 10.DATE OF EVENT EXACT DATE UNKNOWN. 11.WAS THERE ANY PATIENT INVOLVEMENT? PATIENT WAS USING THE NEEDLE DURING DOSING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18424899 ↗
• MalfunctionNov 27, 2023Break; Break

  IT WAS REPORTED THAT THE BD INTEGRA NEEDLE WAS BROKEN. THE FOLLOWING INFORMATION WAS PROVIDED BY THE CUSTOMER: "REPORTS DIFFICULTY WHEN DRAWING OUT DOSE AND HAVING TO PULL NEEDLE ALMOST OUT OF VIAL TO SEE WHEN LIQUID FILLS IN SYRINGE. REPORTS NEEDLE BREAKS AND HAS TO INSERT AND DRAW OUT SYRINGES."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18213622 ↗
• MalfunctionNov 27, 2023Break; Break

  NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18213575 ↗
• MalfunctionNov 27, 2023Complete Blockage; Complete Blockage

  NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18213365 ↗
• MalfunctionNov 18, 2023Complete Blockage; Complete Blockage

  MATERIAL#: 309597, BATCH#: 2263232. IT WAS REPORTED BY THE CUSTOMER THAT THE PATIENT IS ADVISING THAT INJECTION DID NOT WORK TODAY. THE PATIENT STATED THAT THE MEDICATION WOULD NO PASS THROUGH THE NEEDLE AND EVENTUALLY CAME OUT OF THE TOP OF THE SYRINGE INSTEAD AND DID NOT INJECT THROUGH THE NEEDLE. THE PATIENT WILL USE OTHER VIAL FROM KIT FOR DOSE TODAY. NO ADDITIONAL INFORMATION PROVIDED. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. EXTERNAL EVALUATION IS REQUIRED FOR XXX TW (B)(4) ¿ DEFECTIVE DEVICE PRODUCT: GATTEX BD PLASTIC DOSING SYRINGE (1 ML) WITH NEEDLE ATTACHED (26G, 5/8 INCH) BD SYRINGE LOT NUMBER(S): 2263232. THE PATIENT IS ADVISING THAT INJECTION DID NOT WORK TODAY. THE PATIENT STATED THAT THE MEDICATION WOULD NO PASS THROUGH THE NEEDLE AND EVENTUALLY CAME OUT OF THE TOP OF THE SYRINGE INSTEAD AND DID NOT INJECT THROUGH THE NEEDLE. THE PATIENT WILL USE OTHER VIAL FROM KIT FOR DOSE TODAY. NO ADDITIONAL INFORMATION PROVIDED. STATUS: REQUESTING EXTERNAL EVALUATION. COUNTRY OF ORIGIN: UNITED STATES. SAMPLE / PHOTO AVAILABILITY: NO SAMPLE OR PHOTOS WERE PROVIDED TO XXX. AE: NO AE REPORTED. PATIENT IDENTIFIERS AVAILABLE? (I.E. GENDER, WEIGHT, ETHNICITY, E

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18166905 ↗
• MalfunctionOct 10, 2023Volume Accuracy Problem; Volume Accuracy Problem

  IT WAS REPORTED WHILE USING BD¿ LUER SLIP TIP SYRINGE WITH ATTACHED NEEDLE 26 G X 5/8 IN. THERE WERE VOLUME ISSUES. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE PATIENT STATED THAT AFTER INJECTING, MEDICATION HAD RESIDUAL LIQUID IN NEEDLE AND SHE HAS DRAWN OUT A LITTLE EXTRA INTO SYRINGE. PHARMACIST REVIEWED TO ONLY DRAW TO RECOMMENDED DOSE AND THE SYRINGE/NEEDLE ARE CALIBRATED TO ACCOUNT FOR THE MEDICATION STUCK IN NEEDLE. PATIENT STATED THAT SHE WAS PUSHING SYRINGE PLUNGER ALL THE WAY DOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17908696 ↗
• MalfunctionSep 14, 2023Break; Break

  IT WAS REPORTED THAT WHILE REMOVING THE CAP OFF THE BD¿ SLIP-TIP SYRINGE WITH ATTACHED NEEDLE, THE NEEDLE TIP BROKE OFF INTO THE CAP. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "PATIENT REPORTED CONCERNS OF POSSIBLE DAMAGED SUB Q NEEDLES WITH THE CURRENT GATTEX KIT. PATIENT STATED THE CAPS ARE STUCK ON THE NEEDLE TIP AND AT TIMES HAS REMOVED THE NEEDLE TIP WITH THE CAPS. PATIENT DENIES MISSING A DOSE... - HOW WAS THE PATIENT OUTCOME? ARE THERE ANY CLINICAL SIGNS, HEALTH CONSEQUENCES OR IMPACT? AE UNKNOWN, HOWEVER IT WAS STATED THAT THE PATIENT DID NOT MISS A DOSE. ".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17749900 ↗
• MalfunctionAug 4, 2023Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE BD PLASTIPAK¿ 3ML SYRINGE EXPERIENCED LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: LEAKING

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17466730 ↗
• MalfunctionAug 3, 2023Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT 2 OF THE BD PLASTIPAK¿ 3ML SYRINGE EXPERIENCED LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: PATIENT REPORTED HAVING DIFFICULTY WITH THE SYRINGES. PATIENT STATED WHEN INSERTING THE SYRINGE INTO THE GATTEX VIAL, IT STARTED TO LEAK OUT AND WAS UNABLE TO DRAW THE FULL MEDICATION TO SELF-INJECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17452945 ↗
• MalfunctionApr 20, 2023Material Separation; Material Separation

  IT WAS REPORTED WHILE USINGBD¿ LUER SLIP TIP SYRINGE WITH ATTACHED NEEDLE 26 G X 5/8 IN THE NEEDLE PULLED OUT OF THE HUB. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CALLED TO REPORT..."IT WAS THE NEEDLE THAT YOU DRAW THE MEDICATION UP WITH, THE 1 ML SUBQ SYRINGE IN THE KIT. THE NEEDLE PIECE WAS VERY LOOSE AND WHEN SHE INJECTED THE PATIENT, SHE WENT TO PULL IT OUT AND THE NEEDLE STAYED IN HIM, BUT THE WHOLE SYRINGE BARREL REMOVED WHEN SHE WAS GOING TO PULL IT OUT." IS THERE ANY ADVERSE EVENT FOR PATIENT/USER? YES, ADVERSE EVENT WAS REPORTED. WHILE INJECTING PRODUCT, THE PATIENT EXPERIENCED A BURNING SENSATION. NO FURTHER INFORMATION AVAILABLE. WHAT KIND OF MEDICATION USED DURING THE INCIDENT? GATTEX.

  Patient problems: Hot Flashes/Flushes

  MAUDE report 16777748 ↗
• MalfunctionMar 9, 2023Device Markings/Labelling Problem; Device Markings/Labelling Problem

  NO ADDITIONAL INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16519368 ↗
• MalfunctionMar 1, 2023Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE BD¿ SLIP-TIP SYRINGE WITH ATTACHED NEEDLE HAD ISSUES WITH THE MEDICATION LEAKING OUT OF THE VIAL DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "MEDICINE LEAKED OUT OF THE VIAL BOTH TIMES. TWICE THIS HAS HAPPENED IN THE SEVEN MONTHS I HAVE BEEN TAKING IT. FIRST TIME IT HAPPENED WAS THREE MONTHS AGO AND THEN THE SECOND TIME WAS LAST WEEK. WHEN THE MEDICATION LEAKED OUT I DID NOT HAVE ENOUGH MEDICINE TO GIVE MYSELF AN INJECTION EITHER TIME."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16463467 ↗
• MalfunctionMar 1, 2023Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE BD¿ SLIP-TIP SYRINGE WITH ATTACHED NEEDLE HAD ISSUES WITH THE MEDICATION LEAKING OUT OF THE VIAL DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "MEDICINE LEAKED OUT OF THE VIAL BOTH TIMES. TWICE THIS HAS HAPPENED IN THE SEVEN MONTHS I HAVE BEEN TAKING IT. FIRST TIME IT HAPPENED WAS THREE MONTHS AGO AND THEN THE SECOND TIME WAS LAST WEEK. WHEN THE MEDICATION LEAKED OUT I DID NOT HAVE ENOUGH MEDICINE TO GIVE MYSELF AN INJECTION EITHER TIME."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16463424 ↗
• MalfunctionFeb 15, 2023Volume Accuracy Problem; Volume Accuracy Problem

  IT WAS REPORTED THAT 3 OF THE BD¿ SLIP-TIP SYRINGE WITH ATTACHED NEEDLE HAD NO MARKINGS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: NO MARKINGS ON SYRINGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16383632 ↗
• MalfunctionFeb 14, 2023Packaging Problem; Packaging Problem

  IT WAS REPORTED THAT 2 BD¿ SLIP-TIP SYRINGES WITH ATTACHED NEEDLE HAD DAMAGED STERILE PACKAGING. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "WHEN I RECEIVED AND OPENED MY BOX OF GATTEX, THERE WERE 2 SYRINGES THAT WERE NOT IN ANY OF THE PACKAGING. I DID NOT USE THEM AND THREW THEM AWAY... DAMAGED/DEFECTIVE CONTAINER (STERILE)"

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16375877 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K110771. One submission often covers many models, so check the product and lot details in each record.

• Z-2614-2026 · Apr 28, 2026 · Open, Classified
  SYRINGE LUER LOK 10CC-200/BOX BD Product Code: 302995 Mentor Product Code: B9604 Syringe, Piston
• Z-2747-2017 · Sep 16, 2016 · Terminated
  BD 5ml Syringe Luer-Lok" Tip with Blunt Fill Needle 18G x 1 1/2 (1.2mm x 40mm) Catalog #305062
• Z-2751-2017 · Sep 16, 2016 · Terminated
  BD 3ml Syringe Luer-Lok" Tip Catalog 309657 The BD Single Use, Hypodermic Syringe is intended for use by health care professionals for general purpose fluid aspiration/injection
• Z-2752-2017 · Sep 16, 2016 · Terminated
  BD 10mL Syringe Luer-Lok Tip Catalog number 301997 The BD Single Use, Hypodermic Syringe is intended for use by health care professionals for general purpose fluid aspiration/injec
• Z-2750-2017 · Sep 16, 2016 · Terminated
  BD 3ml Syringe Luer-Lok" Tip with BD PrecisionGlide" Needle 18G x 1 1/2 (1.2mm x 40mm) Catalog #309580 The BD Single Use, Hypodermic Syringe is intended for use by health care prof
• Z-2749-2017 · Sep 16, 2016 · Terminated
  BD 3ml Syringe Luer-Lok" Tip with BD PrecisionGlide" Needle 23G x 1 (0.6mm x 25mm) Catalog #309571 The BD Single Use, Hypodermic Syringe is intended for use by health care professi
• Z-2753-2017 · Sep 16, 2016 · Terminated
  BD 3ml Syringer Luer-Lok Tip Catalog #309604 The BD Single Use, Hypodermic Syringe is intended for use by health care professionals for general purpose fluid aspiration/injection
• Z-1936-2016 · Mar 25, 2016 · Terminated
  Henry Schein Single Use Syringe Luer-Lock, 10 mL, Intended for use by health care professionals for general purpose fluid aspiration/injection
• Z-1937-2016 · Mar 25, 2016 · Terminated
  Henry Schein Single Use Syringe Luer-Lock, 10 mL, Intended for use by health care professionals for general purpose fluid aspiration/injection
• Z-1055-2015 · Dec 19, 2014 · Terminated
  BD 10 mL Syringe BD Luer-Lok Tip with Blunt Plastic Cannula, Not for Skin Injection ; Catalog #303348, BD 10 mL Syringe Luer-Lok Tip with Blunt Fill Needle 18G x 1 1/2 (1.2mm x 4