BD Luer-Lok 309570Recalls & reported problems

Summary

The FDA's MAUDE database contains 56 adverse event reports that list this exact device (DI 00382903095704), received between Oct 26, 2017 and May 12, 2026 — classified as 1 injury, 55 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (23 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 56 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 12, 2026Material Integrity Problem

  IT WAS REPORTED THAT BD SYRINGE 3ML LL W/NDL 25X5/8 RB NEEDLE HUB HAD A HOLE OR WAS CRACKED/DAMAGED. COMPLAINT VIA EMAIL. X HAS RECEIVED SYRINGES WHERE THE ATTACHED NEEDLE/COVER IS EITHER BROKEN OR DAMAGED. WE HAVE FOUND THIS ON ONLY 1 LOT OF PARTS. SEE TAB LABELED PICTURES OF DAMAGE. ONE PICTURE SHOW THE PLASTIC HOLDING THE NEEDLE IS ACTUALLY BROKEN AT THE BASE WHERE IT TURNS INTO THE SYRINGE, ONE PICTURE SHOW THE PLASTIC HOLDING THE NEEDLE IS ACTUALLY BROKEN AT THE BASE WHERE IT TURNS INTO THE SYRINGE, AND THE REST OF THE BLUE PLASTIC WITH THE NEEDLE STILL IN THE COVER THE OTHER SHOWS DAMAGE TO THE NEEDLE COVER, LIKE THE NEEDLES/COVERS ARE TURNED ONTO THE SYRINGES BY A MACHINE AND IT WAS GRIPPING TOO TIGHT CAUSING DAMAGE OR ACTUALLY BREAKING THEM. (B)(4). ADDITIONAL INFORMATION: ATTACHED ARE PICTURES OF THE SAMPLE PARTS FOUND. WE HAVE THE PARTS ON HOLD BUT MAY HAVE TO SORT THROUGH BECAUSE SHIPMENTS FROM CARDINAL HEALTH ARE BEING DELAYED AGAIN. WE ARE NOT AT THE MOMENT HAVING PRODUCTION ISSUES DUE TO LACK OF PRODUCT, BUT LAST YEAR WE HAD SIGNIFICANT ISSUES AND DON'T WANT TO BE IN THE SAME BOAT AGAIN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25150837 ↗
• MalfunctionApr 23, 2026Leak/Splash

  IT WAS REPORTED THAT BD SYRINGE 3ML LL W/NDL 25X5/8 RB HAD LEAKAGE. COMPLAINT VIA EMAIL. PLEASE REVIEW THE BRANDED PRODUCT QUALITY COMPLAINT INVOLVING (B)(6) ITEM# 9872220 FROM OUR CUSTOMER. THE CUSTOMER HAS BEEN ISSUED A RETURN LABEL TO RETURN THE PRODUCT FOR EVALUATION. PRODUCT DESCRIPTION: SYRINGES W/NEEDLE LL DISP 3CC. HSI ITEM NUMBER: 9872220. MANUFACTURER PART NUMBER: 309570. LOT OR SERIAL NUMBER: LOT NUMBER: 5345078 ISSUES: THE OFFICE RECEIVED SYRINGES THAT ARE LEAKING PER FSC.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24972761 ↗
• MalfunctionJan 7, 2026Leak/Splash

  NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23989165 ↗
• MalfunctionJul 22, 2025Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE BD SYRINGE 3ML LL W/NDL 25X5/8 RB HAD LEAKAGE PAST THE STOPPER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL # 309570 BATCH # UNKNOWN VERBATIM: RCC RECEIVED A COMPLAINT VIA PHONE. PIR ATTACHED. PRODUCT COMPLAINT CANADA COMPLAINT REF 309570 LOT UNKNOWN. ISSUE: SO WHEN ADMINISTERING INJECTION MEDICATION LEAKED BEHIND THE PLUNGER. SAMPLE ACTUAL DEVICE WAS DISCARDED BUT PICTURES ARE AVAILABLE DOE (B)(6) 2025 NO PT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22572033 ↗
• MalfunctionMay 5, 2025Break; Break

  IT WAS REPORTED THAT THE BD SYRINGE 3ML LL W/NDL 25X5/8 RB NEEDLE PULLED OUT OF THE HUB. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL #309570. LOT #2075223. VERBATIM: RCC RECEIVED A COMPLAINT VIA PHONE. PIR ATTACHED. CUSTOMER STATES THAT WHILE USING ITEM 309570; LOT 2075223, THE NEEDLE FELL OFF WHERE IT CONNECTS TO THE BLUE PART. NO NEEDLE STICK. CUSTOMER HAS PRODUCT TO RETURN IF NEEDED. CUSTOMER WOULD LIKE REPLACEMENT AS SHE ONLY GETS 4 NEEDLES PER MONTH AND WITH THIS INCIDENT, SHE IS SHORT A NEEDLE FOR THE MONTH OF APRIL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21959209 ↗
• MalfunctionJan 22, 2025Connection Problem; Connection Problem

  MATERIAL # 309570, BATCH # 1161233. IT WAS REPORTED THAT THE BD SYRINGE 3ML LL W/NDL 25X5/8 RB HAD A SYRINGE NEEDLE CONNECTIVITY ISSUE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. NEEDLE COMES OFF OF SYRINGE ITEM(S): 309570, LOT(S): 1161233. DATE INCIDENT OCCURRED: ON GOING WAS THE PATIENT IMPACTED? YES, NEEDLE COMES OFF OF SYRINGE IF YES, DESCRIBE: 3 BOTTLES OF B12 WASTED IS A SAMPLE AVAILABLE?: YES. CUSTOMER REQUEST?: NEEDING REIMBURSEMENT FOR SYRINGES AND B12. CUSTOMER RESPONSE ON (B)(6) 2025. THAT¿S WHAT YOU CALL REALLY BAD MULTI-TASKING. SORRY. YES, I WAS WAITING FOR YOU TO CONTACT ME ABOUT THE BAD SYRINGES AND THE LOSS OF THREE BOTTLE SO MY B12 SERUM, WHICH IS COSTLY. THE BAD SYRINGES OCCURRED ON THESE DATES: (B)(6) 24 AND (B)(6) 2025. I DID NOT GET A SHIPPING LABEL AND I¿M NOT SURE WHAT YOU WANT ME TO RETURN. I DISCARDED TWO OF THE THREE BAD SYRINGES. I HAVE THE OPEN AND NOW USELESS B12 BOTTLES AND TWO OF THE PHARMACY BOTTLES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21211771 ↗
• MalfunctionJan 22, 2025Connection Problem; Connection Problem

  NO ADDITIONAL INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21211770 ↗
• MalfunctionJan 22, 2025Connection Problem; Connection Problem

  NO ADDITIONAL INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21211763 ↗
• MalfunctionSep 23, 2024Volume Accuracy Problem; Volume Accuracy Problem

  NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20288231 ↗
• MalfunctionJun 19, 2024Complete Blockage; Complete Blockage

  NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19570970 ↗
• MalfunctionAug 4, 2023Leak/Splash; Leak/Splash

  IT WAS REPORTED BY THE CUSTOMER THAT WHILE USING THE BD LUER-LOK¿ SYRINGE WAS LEAKING. REPORT 2 OF 2. THE FOLLOWING WAS RECEIVED BY THE INITIAL REPORTER: CUSTOMER REPORTED THAT THE PATIENT IS OUT OF REMODULIN BECAUSE YESTERDAY SHE HAD ISSUES WHEN MAKING THE NEW CASSETTE AND SHE ENDED UP WASTING MEDICATION FOR 2 CASSETTES. SHE REPORTED THAT WHEN SHE MADE THE FIRST CASSETTE, THE TIP OF THE NEEDLE BROKE INSIDE AND THE SECOND CASSETTE WAS LEAKING. BOTH CASSETTES WERE DISCARDED. SHE DID NOT PROVIDE ANY LOT NUMBERS FOR THE AFFECTED CASSETTES. THE THIRD CASSETTE CREATED YESTERDAY WAS FINE AND THAT IS WHAT THE PATIENT IS CURRENTLY USING. PATIENT IS ON SUBCUTANEOUS REMODULIN THERAPY USING REMUNITY PUMPS. PATIENT'S MOTHER DID NOT REPORT THAT PATIENT EXPERIENCED ANY CHANGES IN BREATHING OR SIDE EFFECTS. NO OTHER INFORMATION PROVIDED. SUBCUTANEOUS SELF-FILL REMUNITY PT. PT ACTIVELY ON UPTRAVI AND TADALAFIL. DID THE PRODUCT ISSUE CAUSE OR CONTRIBUTE TO PATIENT OR CLINICAL INJURY? NO. IF YES, WAS ANY MEDICAL INTERVENTION PROVIDED? PLEASE EXPLAIN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17466787 ↗
• MalfunctionAug 4, 2023Break; Break

  IT WAS REPORTED BY THE CUSTOMER THAT WHILE USING THE BD LUER-LOK SYRINGE THE NEEDLE BROKE. REPORT 1 OF 2. THE FOLLOWING WAS RECEIVED BY THE INITIAL REPORTER: CUSTOMER REPORTED THAT THE PATIENT IS OUT OF REMODELING BECAUSE YESTERDAY SHE HAD ISSUES WHEN MAKING THE NEW CASSETTE AND SHE ENDED UP WASTING MEDICATION FOR 2 CASSETTES. SHE REPORTED THAT WHEN SHE MADE THE FIRST CASSETTE, THE TIP OF THE NEEDLE BROKE INSIDE AND THE SECOND CASSETTE WAS LEAKING. BOTH CASSETTES WERE DISCARDED. SHE DID NOT PROVIDE ANY LOT NUMBERS FOR THE AFFECTED CASSETTES. THE THIRD CASSETTE CREATED YESTERDAY WAS FINE AND THAT IS WHAT THE PATIENT IS CURRENTLY USING. PATIENT IS ON SUBCUTANEOUS REMODELING THERAPY USING REMUNITY PUMPS. PATIENT'S MOTHER DID NOT REPORT THAT PATIENT EXPERIENCED ANY CHANGES IN BREATHING OR SIDE EFFECTS. SUBCUTANEOUS SELF-FILL REMUNITY PT. PT ACTIVELY ON UPTRAVI AND TADALAFIL. DID THE PRODUCT ISSUE CAUSE OR CONTRIBUTE TO PATIENT OR CLINICAL INJURY? NO. IF YES, WAS ANY MEDICAL INTERVENTION PROVIDED? PLEASE EXPLAIN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17466784 ↗
• MalfunctionJul 24, 2023Device Misassembled During Manufacturing /Shipping; Device Misassembled During Manufacturing /Shipping

  IT WAS REPORTED THAT PRIOR TO USE WITH BD 3ML LL NEEDLE 25G 5/8IN REGULAR BEVEL MIXED PRODUCT WAS DISCOVERED IN SHELF/CARTON. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: DIFFERENT SIZE NEEDLES IN 1 BOX, ALL SEALED. ADDITIONAL INFORMATION RECEIVED: IS IT NEEDLE LENGTH OR NEEDLE GAUGE (GA) SIZES IN 1 BOX ONLY OR DID YOU RECEIVE MIXED UP PRODUCT IN A SHELF/CARTON? SURE, I WENT BACK AND TOOK EACH NEEDLE OUT OF THE BOX AND THEY ALL HAD THE SAME LOT NUMBER/ITEM NUMBER EXCEPT FOR ONE. THEY PROBABLY JUST THREW IT IN THE BOX. SO THERE WERE NOT DIFFERENT SIZES IN THE BOX.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17385508 ↗
• MalfunctionJun 13, 2023Complete Blockage; Complete Blockage

  IT WAS REPORTED WHILE USING BD LUER-LOK¿ SYRINGE WITH ATTACHED NEEDLE THE NEEDLE WAS CLOGGED. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: TWO FAULTY NEEDLES ONE NOT USE AND ONE NEEDLESS GOOD IN OPEN PACKAGE USED 1 NEEDLE FELL APART AND THE OTHER NEEDLE WOULD NOT DRAW THE MEDICINE FROM THE BOTTLE NO ONE WAS HURT THANK GOD THE NEEDLE BROKE OFF IN THE BOTTLE INSTEAD OF IN ME. CAN YOU PLEASE PROVIDE ADDITIONAL DETAILS OF THE PRODUCT MALFUNCTION YOU REPORTED? (DETAILED DESCRIPTION OF EVENT) ¿ STATED AS ABOVE. WHAT WAS THE PATIENT IMPACT? NO INJURY REPORTED. WHAT WAS THE PATIENT OUTCOME? NO INJURY REPORTED, CONSUMER USE GOOD NEEDLE. WAS THERE ANY MEDICAL INTERVENTION? NO. CAN YOU PLEASE PROVIDE THE DATE OF EVENT? CONSUMER DIDN'T PROVIDE EVENT DATE. IS A SAMPLE AVAILABLE FOR EVALUATION? CONSUMER DIDN'T PROVIDE SAMPLE AVAILABILITY INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17119971 ↗
• MalfunctionJun 2, 2023Break; Break

  IT WAS REPORTED THAT AN UNSPECIFIED AMOUNT OF BD LUER-LOK¿ SYRINGES' NEEDLES BROKE DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "SPONTANEOUS. PATIENT'S CAREGIVER STATED THE PATIENT REPORTED THAT THE PREVIOUS NEEDLES WERE BREAKING AND HURTING AT INJECTION SITE. SHE ALSO CONFIRMED THAT THERE ARE NO OTHER SIDE EFFECTS FROM THE MEDICATION. UNKNOWN IF PT MISSED ANY DOSES, EXPERIENCED ANY SIDE EFFECTS OR IF PRODUCT ON HAND FOR RETURN. ALL KNOWN INFORMATION WAS PROVIDED ON THE REPORT. THERE IS NO FURTHER INFORMATION KNOWN AT THIS TIME."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17049141 ↗
• MalfunctionMay 24, 2023Break; Break

  IT WAS REPORTED THAT THE BD LUER-LOK¿ SYRINGE WITH ATTACHED NEEDLE BROKE OFF WHILE INSERTED INTO A DOG'S NECK. TWO X-RAYS WERE TOOK AFTER THE INCIDENT AND SURGERY WAS PERFORMED TO REMOVE THE NEEDLE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WE HAD A BD PLASTIPAK 3ML SYRINGE WITH 25G X 5/8 NEEDLE, WHERE THE NEEDLE BROKE OFF UNDER THE PET'S SKIN. I WOULD LIKE TO MAKE THE COMPANY ( BD , BECTON, DICKINSON AND COMPANY ) AWARE OF THIS SAFETY CONCERN. IT BROKE OFF AT THE HUB'S BASE. ADDITIONAL INFO RECEIVED ON 3MAY2023 HOW DID THE HUB BREAK? THE NEEDLE BROKE OFF AT THE HUB BASE WHILE INSERTED INTO A DOG'S NECK FOR A JUGULAR DRAW ; PATIENT WAS SPIKE IKE, INCIDENT WAS (B)(6) 2023. WHEN THE BREAK DISCOVERED? BEFORE USE, DURING USE OR AFTER USE? DURING AND AFTER - WHEN THE SAMPLE WAS NOT FLOWING INTO THE SYRINGE. IS THERE ANY ADVERSE EVENT TO THE PATIENT? HE HAD TO UNDERGO A PROCEDURE TO REMOVE THE NEEDLE FROM UNDER SKIN, BUT HE RECOVERED COMPLETELY . IF YOU ARE UNABLE TO SEND A SAMPLE, CAN A PHOTO BE PROVIDED? ATTACHED ARE TWO X-RAYS WE TOOK IMMEDIATELY - FOLLOWING THE DISCOVERY OF THE NEEDLE BREAKING OFF.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16994784 ↗
• MalfunctionMay 19, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT MULTIPLE BD LUER-LOK¿ SYRINGES HAD THE NEEDLE HUB SEPARATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THESE ARE THE NEEDLES AND DEFECTS".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16964733 ↗
• MalfunctionMay 18, 2023Break; Break

  IT WAS REPORTED THAT 3 BD LUER-LOK¿ SYRINGES HAD BROKEN BARRELS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "CUSTOMER GOT (B)(4)SYRINGES AND ONLY (B)(4) WORKED. SYRINGES WERE BROKEN AND WEREN'T ABLE TO DRAW MEDICINE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16959321 ↗
• MalfunctionMay 8, 2023Break; Break

  IT WAS REPORTED THAT THE BD LUER-LOK¿ SYRINGE NEEDLE BROKE OFF UNDER THE PET'S SKIN. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WE HAD A BD PLASTIPAK 3ML SYRINGE WITH 25G X 5/8 NEEDLE, WHERE THE NEEDLE BROKE OFF UNDER THE PET'S SKIN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16892206 ↗
• MalfunctionMay 5, 2023Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT 25 1" BD LUER-LOK¿ SYRINGES' LABELING STATED THEY WERE 5/8". THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "25 OUT OF 50 SYRINGES WERE LABELED WRONG. THE WRAPPING SAYS 25 GAUGE 5/8, BUT THE NEEDLE INSIDE IS ACTUALLY 1¿. WHEN DID THIS DEFECTIVE ITEM WAS FOUND OUT, BEFORE, DURING OR AFTER USE? WHEN OUR CUSTOMER UNWRAPPED THE PRODUCT. WAS THERE ANY PATIENT INVOLVEMENT? IS THERE ANY ADVERSE EVENT REPORTED? NO. WAS THERE A DELAY OF, OR CHANGE IN, THE COURSE OF TREATMENT DUE TO THE EVENT? NO. BECAUSE 25 SYRINGES WERE THE CORRECT SIZE. WHAT TYPE OF PROCEDURE IS BEING PERFORMED? N/A".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16882171 ↗
• MalfunctionApr 12, 2023Break; Leak/Splash; Break; Leak/Splash

  IT WAS REPORTED THAT THE BD LUER-LOK¿ SYRINGE WAS DEFECTIVE CAUSING LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: RECEIVED A DEFECTIVE SYRINGE WITH B12 INJECTABLE THE DEFECTIVE SYRINGE LEAKED THE B12 SOLUTION ALL OVER THE FLOOR

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16728986 ↗
• MalfunctionApr 1, 2023Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT LEAKAGE OCCURRED BETWEEN THE BD LUER-LOK¿ SYRINGE AND NEEDLE WHILE DRAWING UP THE VACCINE. THIS COMPLAINT WAS CREATED TO CAPTURE THE 1ST OF 2 RELATED INCIDENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "CUSTOMER ATTEMPTED TO DRAW UP VACCINE AND WHILE THAT HAPPENED CREATED A LEAK BETWEEN THE NEEDLE AND SYRINGE. PHARMACIST ALWAYS MAKE SURE TO SECURE NEEDLE AND SYRINGE (TIGHTEN AND CHECKED BEFORE USE). 2 SEPARATE INCIDENTS. ONE DATE IS (B)(6) 2023 AND THE OTHER UNKNOWN. NO PATIENT INVOLVEMENT, DID WASTE EXPENSIVE VACCINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16660853 ↗
• MalfunctionApr 1, 2023Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT LEAKAGE OCCURRED BETWEEN THE BD LUER-LOK¿ SYRINGE AND NEEDLE WHILE DRAWING UP THE VACCINE. THIS COMPLAINT WAS CREATED TO CAPTURE THE 2ND OF 2 RELATED INCIDENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "CUSTOMER ATTEMPTED TO DRAW UP VACCINE AND WHILE THAT HAPPENED CREATED A LEAK BETWEEN THE NEEDLE AND SYRINGE. PHARMACIST ALWAYS MAKE SURE TO SECURE NEEDLE AND SYRINGE (TIGHTEN AND CHECKED BEFORE USE). 2 SEPARATE INCIDENTS. ONE DATE IS (B)(6) 2023 AND THE OTHER UNKNOWN. NO PATIENT INVOLVEMENT, DID WASTE EXPENSIVE VACCINE"

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16660852 ↗
• MalfunctionMar 25, 2023Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED WHILE USING BD LUER-LOK¿ SYRINGE WITH ATTACHED NEEDLE FOREIGN MATTER WAS FOUND. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: USING THE SYRINGES TO ADMINISTER VACCINES 2 OF THE SYRINGES HAD GEL-LIKE STICKY SUBSTANCE INSIDE THE SYRINGE CUSTOMER WANTED TO KNOW WHAT THIS SUBSTANCE MIGHT BE TRANSFERRED TO MED INFO.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16616539 ↗
• MalfunctionJan 12, 2023Leak/Splash; Separation Problem; Leak/Splash; Separation Problem

  IT WAS REPORTED THAT THE BD LUER-LOK¿ SYRINGE AND NEEDLE SEPARATED DURING THE VACCINE ADMINISTRATION, CAUSING THE VACCINE TO LEAK OUT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "ON 12/13/22 ONE OF MY NURSES WAS DRAWING UP A VACCINE AND THE NEEDLE CAME AWAY FROM THE SYRINGE CAUSING THE VACCINE TO BE A LOSS."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16154645 ↗

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-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-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-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-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-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-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-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