N/A 309626Recalls & reported problems

Summary

The FDA's MAUDE database contains 77 adverse event reports that list this exact device (DI 00382903096268), received between Nov 27, 2017 and Feb 17, 2026 — classified as 1 injury, 76 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (24 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 77 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 17, 2026Material Perforation

  NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Needle Stick/Puncture

  MAUDE report 24366904 ↗
• MalfunctionApr 23, 2024Material Puncture/Hole; Material Puncture/Hole

  MATERIAL# 309626 BATCH# 3251983 IT WAS REPORTED THAT THE BD SYRINGE 1ML S/T W/NDL 25X5/8 RB NEEDLE WAS THROUGH THE SHIELD. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "SYRINGE WAS UNPACKAGED AS STAFF NOTICED THAT THE NEEDLE HAS PENETRATED THE CAP." VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. GPOID: H002711 COID: A0511 CONTRACT NUMBER: 132 MANUFACTURER: BD MEDICAL DEAR VENDOR, PLEASE REVIEW AND PROVIDE A RESPONSE TO THE PRODUCT QUALITY ISSUE REPORTED. PLEASE CONTACT THE FACILITY DIRECTLY FOR DETAILS, SAMPLE COLLECTION AND RESOLUTION. WHEN THE INVESTIGATION HAS COMPLETED, PLEASE PROVIDE HEALTHTRUST WITH A COPY OF THE FINAL LETTER IN ORDER TO CLOSE OUT THE TICKET IN THE HEALTHTRUST DATABASE. I WILL FOLLOW UP WITH YOU FOR A STATUS UPDATE IN A COUPLE OF WEEKS. FACILITY CONTACT: (B)(6). PRODUCT CATALOG NUMBER: 309626 PRODUCT DESCRIPTION: LUER SLIP TIP SYRINGE WITH ATTACHED NEEDLE 25 G X 5/8 IN., STERILE, SINGLE USE, 1 ML ORIGIN OF THE ISSUE: STAFF SAFETY DETAIL: SYRINGE WAS UNPACKAGED AS STAFF NOTICED THAT THE NEEDLE HAS PENETRATED THE CAP NUMBER OF OCCURRENCES: 1.0 SAMPLE AVAILABLE: TRUE LOT NUMBER: 3251983.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19169784 ↗
• MalfunctionApr 18, 2024Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  MATERIAL#: 309626 BATCH#:UNKNOWN IT WAS REPORTED THAT THE BD SYRINGE 1ML S/T W/NDL 25X5/8 RB HAD FOREIGN MATTER. IT WAS REPORTED BY THE CUSTOMER THAT THE BASE END OF THE NEEDLE AT THE HUB THERE IS A DRIP OF EXCESS SILICONE OR PLASTIC HANGING ONTO THE NEEDLE. FEW MILLIMETERS OF THIS FOREIGN MATTER. PATIENT SAID THAT THE INSERTION WAS PAINFUL AS WELL. VERBATIM: NURSE CALLING ON BEHALF OF PATIENT WHO PICKED UP BOX OF NEEDLES FROM PHARMACY LAST WEEK. THE BASE END OF THE NEEDLE AT THE HUB THERE IS A DRIP OF EXCESS SILICONE OR PLASTIC HANGING ONTO THE NEEDLE. FEW MILLIMETERS OF THIS FOREIGN MATTER. PATIENT SAID THAT THE INSERTION WAS PAINFUL AS WELL. DELAY IN TREATMENT PHARMACY DID NOT REPLACE NEEDLES BECAUSE THEY DIDN'T SEE THE DEFECT. PHOTOS ARE AVAILABLE OF THIS FAILURE DATE OF EVENT- UNKNOWN HAPPENED LAST WEEK HE SAID THE ENTIRE BOX OF NEW NEEDLES ALL HAVE THIS CONDITION. REF 309626 NDC- (B)(4). ADDITIONAL INFORMATION PROVIDED ON 04/12/2024: HI, SORRY FOR THE DELAYED RESPONSE. I DON¿T KNOW THE ANSWER TO MOST OF THESE QUESTIONS, UNFORTUNATELY. I DIDN¿T REALIZE THERE WOULD BE ADDITIONAL STEPS, SO I DON¿T EVEN HAVE THE PATIENT¿S INFORMATION HANDY AT THIS POINT. THE PATIENT REPORTED INCR

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19139927 ↗
• MalfunctionApr 2, 2024Connection Problem; Connection Problem

  IT WAS REPORTED THAT THE BD SYRINGE 1ML S/T W/NDL 25X5/8 RB HAD A SYRINGE NEEDLE CONNECTIVITY ISSUE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "WHEN REMOVING THE CAP THE NEEDLE IS DETACHING FROM THE SYRINGES." PRODUCTCOMPLAINT XXXX -RN REPORTING ON HER LAST DAY ELON STUDENT HEALTH AND WELLNESS XXXXXX XXXXX EMAIL: XXXXX PHONE: XXXXX XXXXX EMAIL: XXXX (B)(6) ISSUE: WHEN REMOVING THE CAP THE NEEDLE IS DETACHING FROM THE SYRINGES. REF: (B)(4) LOTS: 3271607 DOE: (B)(6) 2024 PT HARM: NO SAMPLES: YES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19029547 ↗
• MalfunctionMar 18, 2024Disconnection; Disconnection

  IT WAS REPORTED THAT THE BD SYRINGE 1ML S/T W/NDL 25X5/8 RB HAD A NEEDLE CONNECTIVITY ISSUE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED BY CUSTOMER THAT WE KEEP FINDING NEEDLES THAT ARE BENT AND STICKING OUT OF THE CAPS THAT JAB US WHEN WE OPEN THEM (CLEARLY A MANUFACTURING PROBLEM WITH POOR QUALITY CONTROL, BUT A MAJOR SAFETY ISSUE!) -LABEL STICKERS DO NOT STICK TO THESE SYRINGES BECAUSE THEY ARE COATED IN SOMETHING SLIPPERY, SO IT MAKES IT VERY CHALLENGING TO LABEL SUBSTANCES IN THEM WHEN WE DRAW UP INJECTIONS AND WE ARE TERRIFIED IT COULD RESULT IN GIVING THE WRONG INJECTIONS, SO IT HAS REALLY DESTROYED OUR USUAL SURGERY DAY FLOW BECAUSE WE CANNOT SAFELY DRAW UP ALL INJECTIONS AHEAD OF TIME FOR SMALL PATIENTS -NEEDLES DON'T STAY ON THE END OF THESE AT ALL! JUST THIS MORNING, I DOUSED MYSELF, MY ASSISTANT, AND AN OWNER IN EUTHANASIA SOLUTION WHEN I ATTEMPTED TO EUTHANIZE A RAT. WE ALL GOT FATAL PLUS IN OUR MOUTHS AND EYES. OBVIOUSLY, THIS NOT ONLY IS A HUGE LIABILITY, BUT IT IS COSTING ME A TON OF MONEY IN INJECTABLE MEDICATIONS THAT HAVE TO BE DRAWN UP AGAIN WHEN THEY LEAK OUT OF FAULTY SYRINGES AND PUTS PETS AT RISK OF OVERDOSE BECAUSE SOMET

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18924605 ↗
• MalfunctionMar 18, 2024Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT THE BD SYRINGE 1ML S/T W/NDL 25X5/8 RB NEEDLE WENT THROUGH THE SHIELD. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED BY CUSTOMER THAT WE KEEP FINDING NEEDLES THAT ARE BENT AND STICKING OUT OF THE CAPS THAT JAB US WHEN WE OPEN THEM (CLEARLY A MANUFACTURING PROBLEM WITH POOR QUALITY CONTROL, BUT A MAJOR SAFETY ISSUE!) LABEL STICKERS DO NOT STICK TO THESE SYRINGES BECAUSE THEY ARE COATED IN SOMETHING SLIPPERY, SO IT MAKES IT VERY CHALLENGING TO LABEL SUBSTANCES IN THEM WHEN WE DRAW UP INJECTIONS AND WE ARE TERRIFIED IT COULD RESULT IN GIVING THE WRONG INJECTIONS, SO IT HAS REALLY DESTROYED OUR USUAL SURGERY DAY FLOW BECAUSE WE CANNOT SAFELY DRAW UP ALL INJECTIONS AHEAD OF TIME FOR SMALL PATIENTS NEEDLES DON'T STAY ON THE END OF THESE AT ALL! JUST THIS MORNING, I DOUSED MYSELF, MY ASSISTANT, AND AN OWNER IN EUTHANASIA SOLUTION WHEN I ATTEMPTED TO EUTHANIZE A RAT. WE ALL GOT FATAL PLUS IN OUR MOUTHS AND EYES. OBVIOUSLY, THIS NOT ONLY IS A HUGE LIABILITY, BUT IT IS COSTING ME A TON OF MONEY IN INJECTABLE MEDICATIONS THAT HAVE TO BE DRAWN UP AGAIN WHEN THEY LEAK OUT OF FAULTY SYRINGES AND PUTS PETS AT RISK OF OVERDOSE BECAUSE SOMETIME

  Patient problems: Needle Stick/Puncture

  MAUDE report 18924441 ↗
• MalfunctionMar 11, 2024Material Puncture/Hole; Material Puncture/Hole

  NO ADDITIONAL INFORMATION.

  Patient problems: Insufficient Information

  MAUDE report 18882473 ↗
• MalfunctionFeb 26, 2024Leak/Splash; Leak/Splash

  MATERIAL #: 309626 BATCH#: 3058292, 3150938, 2341837, 3048203. IT WAS REPORTED BY CUSTOMER THAT DURING THE INJECT THE MEDICATION IS LEAKING FROM THE HUB SO THE PATIENTS ARE NOT GETTING THE FULL VACCINE. THEY ARE HAVING TO RE-STICK THE PATIENTS TO MAKE SURE THEY GET THE VACCINE. WHEN THEY DRAW UP THE MEDICATION AND THEY HAVE TO RECAP THE NEEDLE, THEY HAVE HAD 2 NEEDLE STICKS DUE TO THE BEVEL PENETRATING THE CAP. 2 CLEAN NEEDLES LAST MONTH LAST AND, IN THE FALL, NOT SURE OF THE DAYS. NURSES JUST CLEANED IT OFF AND COVERED. VERBATIM: RCC RECEIVED A COMPLAINT VIA MAIL. PIR ATTACHED. (B)(6). FAULTY SYRINGE MATERIAL 309626 LOT 3058292, 3150938, 2341837, 3048203 DURING THE INJECT THE MEDICATION IS LEAKING FROM THE HUB SO THE PATIENTS ARE NOT GETTING THE FULL VACCINE. THEY ARE HAVING TO RESTICK THE PATIENTS TO MAKE SURE THEY GET THE VACCINE. WHEN THEY DRAW UP THE MEDICATION AND THEY HAVE TO RECAP THE NEEDLE, THEY HAVE HAD 2 NEEDLE STICKS DUE TO THE BEVEL PENETRATING THE CAP. 2 CLEAN NEEDLES LAST MONTH LAST AND IN THE FALL NOT SURE OF THE DAYS. NURSES JUST CLEANED IT OFF AND COVERED. CUSTOMER DOES HAVE THE SAMPLES AVAILABLE FOR THE INVESTIGATION. THEY ORDER FROM CONCORDANCE HEALTH AND WOULD

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18784151 ↗
• MalfunctionFeb 26, 2024Leak/Splash; Leak/Splash

  MATERIAL #: 309626. BATCH#: 3058292, 3150938, 2341837, 3048203. IT WAS REPORTED BY CUSTOMER THAT DURING THE INJECT THE MEDICATION IS LEAKING FROM THE HUB SO THE PATIENTS ARE NOT GETTING THE FULL VACCINE. THEY ARE HAVING TO RE-STICK THE PATIENTS TO MAKE SURE THEY GET THE VACCINE. WHEN THEY DRAW UP THE MEDICATION AND THEY HAVE TO RECAP THE NEEDLE, THEY HAVE HAD 2 NEEDLE STICKS DUE TO THE BEVEL PENETRATING THE CAP. 2 CLEAN NEEDLES LAST MONTH LAST AND, IN THE FALL, NOT SURE OF THE DAYS. NURSES JUST CLEANED IT OFF AND COVERED. VERBATIM: RCC RECEIVED A COMPLAINT VIA MAIL. (B)(6) NURSE (B)(6). FAULTY SYRINGE MATERIAL 309626 LOT 3058292, 3150938, 2341837, 3048203. DURING THE INJECT THE MEDICATION IS LEAKING FROM THE HUB SO THE PATIENTS ARE NOT GETTING THE FULL VACCINE. THEY ARE HAVING TO RESTICK THE PATIENTS TO MAKE SURE THEY GET THE VACCINE. WHEN THEY DRAW UP THE MEDICATION AND THEY HAVE TO RECAP THE NEEDLE, THEY HAVE HAD 2 NEEDLE STICKS DUE TO THE BEVEL PENETRATING THE CAP. 2 CLEAN NEEDLES LAST MONTH LAST AND IN THE FALL NOT SURE OF THE DAYS. NURSES JUST CLEANED IT OFF AND COVERED. CUSTOMER DOES HAVE THE SAMPLES AVAILABLE FOR THE INVESTIGATION. THEY ORDER FROM CONCORDANCE HEALTH AND WOUL

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18784150 ↗
• MalfunctionFeb 26, 2024Leak/Splash; Leak/Splash

  MATERIAL #: 309626 BATCH#: 3058292, 3150938, 2341837, 3048203.IT WAS REPORTED BY CUSTOMER THAT DURING THE INJECT THE MEDICATION IS LEAKING FROM THE HUB SO THE PATIENTS ARE NOT GETTING THE FULL VACCINE. THEY ARE HAVING TO RE-STICK THE PATIENTS TO MAKE SURE THEY GET THE VACCINE. WHEN THEY DRAW UP THE MEDICATION AND THEY HAVE TO RECAP THE NEEDLE, THEY HAVE HAD 2 NEEDLE STICKS DUE TO THE BEVEL PENETRATING THE CAP. 2 CLEAN NEEDLES LAST MONTH LAST AND, IN THE FALL, NOT SURE OF THE DAYS. NURSES JUST CLEANED IT OFF AND COVERED. VERBATIM:RCC RECEIVED A COMPLAINT VIA MAIL. PIR ATTACHED. (B)(6) NURSEFAULTY SYRINGE MATERIAL 309626 LOT 3058292, 3150938, 2341837, 3048203DURING THE INJECT THE MEDICATION IS LEAKING FROM THE HUB SO THE PATIENTS ARE NOT GETTING THE FULL VACCINE. THEY ARE HAVING TO RESTICK THE PATIENTS TO MAKE SURE THEY GET THE VACCINE.WHEN THEY DRAW UP THE MEDICATION AND THEY HAVE TO RECAP THE NEEDLE, THEY HAVE HAD 2 NEEDLE STICKS DUE TO THE BEVEL PENETRATING THE CAP. 2 CLEAN NEEDLESLAST MONTH LAST AND IN THE FALL NOT SURE OF THE DAYS.NURSES JUST CLEANED IT OFF AND COVERED. CUSTOMER DOES HAVE THE SAMPLES AVAILABLE FOR THE INVESTIGATION. THEY ORDER FROM CONCORDANCE HEALTH AND WOULD

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18784149 ↗
• MalfunctionFeb 26, 2024Leak/Splash; Leak/Splash

  MATERIAL #: 309626 BATCH#: 3058292, 3150938, 2341837, 3048203. IT WAS REPORTED BY CUSTOMER THAT DURING THE INJECT THE MEDICATION IS LEAKING FROM THE HUB SO THE PATIENTS ARE NOT GETTING THE FULL VACCINE. THEY ARE HAVING TO RE-STICK THE PATIENTS TO MAKE SURE THEY GET THE VACCINE. WHEN THEY DRAW UP THE MEDICATION AND THEY HAVE TO RECAP THE NEEDLE, THEY HAVE HAD 2 NEEDLE STICKS DUE TO THE BEVEL PENETRATING THE CAP. 2 CLEAN NEEDLES LAST MONTH LAST AND, IN THE FALL, NOT SURE OF THE DAYS. NURSES JUST CLEANED IT OFF AND COVERED. VERBATIM: RCC RECEIVED A COMPLAINT VIA MAIL. PIR ATTACHED. (B)(6). FAULTY SYRINGE MATERIAL 309626 LOT 3058292, 3150938, 2341837, 3048203. DURING THE INJECT THE MEDICATION IS LEAKING FROM THE HUB SO THE PATIENTS ARE NOT GETTING THE FULL VACCINE. THEY ARE HAVING TO RESTICK THE PATIENTS TO MAKE SURE THEY GET THE VACCINE. WHEN THEY DRAW UP THE MEDICATION AND THEY HAVE TO RECAP THE NEEDLE, THEY HAVE HAD 2 NEEDLE STICKS DUE TO THE BEVEL PENETRATING THE CAP. 2 CLEAN NEEDLES LAST MONTH LAST AND IN THE FALL NOT SURE OF THE DAYS. NURSES JUST CLEANED IT OFF AND COVERED. CUSTOMER DOES HAVE THE SAMPLES AVAILABLE FOR THE INVESTIGATION. THEY ORDER FROM CONCORDANCE HEALTH AND WOUL

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18784121 ↗
• MalfunctionDec 10, 2023Material Puncture/Hole; Material Puncture/Hole

  NO ADDITIONAL INFORMATION.

  Patient problems: Needle Stick/Puncture

  MAUDE report 18298498 ↗
• MalfunctionDec 4, 2023Delivered as Unsterile Product; Delivered as Unsterile Product

  IT WAS REPORTED THAT THE BD SYRINGE 1ML S/T W/NDL 25X5/8 RB NEEDLE WAS THROUGH THE SHIELD. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THE CUSTOMER HAS HAD MULTIPLE COMBO NEEDLES AND SYRINGES WHERE THE NEEDLE IS STICKING THROUGH THE CAP."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18259409 ↗
• MalfunctionDec 3, 2023Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT THE BD SYRINGE 1ML S/T W/NDL 25X5/8 RB HAD A SCALE MARKING ISSUE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "UNIT OF MEASURE PRINTED DOWN SYRINGE ISN'T STRAIGHT AND DOESN'T MATCH UP TO DRAW UP CORRECT DOSE - MOST OF THESE HAVE BEEN TOSSED." FURTHER INFORMATION RECEIVED ON 11/19/2023: IF YOU ARE UNABLE TO SEND A SAMPLE, COULD YOU PROVIDE ANY PHOTO/VIDEO OF THE REPORTED ISSUE? NO. I REPORTED IT TO THE VENDOR (COVETRUS) AND DISPOSED OF THE TUB. WHAT IS THE OUTCOME? ARE THERE ANY ADVERSE EVENTS/SERIOUS INJURIES? NO. WHEN THE DEFECT WAS NOTICED IT WAS BROUGHT TO MY ATTENTION. WAS THERE A DELAY OF, OR CHANGE IN, THE COURSE OF TREATMENT DUE TO THE EVENT? YES. HAD TO PULL A NEW NEEDLE. WHAT TYPE OF PROCEDURE IS BEING PERFORMED? BLOOD DRAW, AND SEDATIVE INJECTION. WHAT WAS THE MEDICATION/FLUID IN USE AT THE TIME OF THE EVENT? UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18253697 ↗
• MalfunctionOct 12, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  NO ADDITIONAL INFORMATION.

  Patient problems: Needle Stick/Puncture

  MAUDE report 17925881 ↗
• MalfunctionMay 25, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE NEEDLE OF THE BD¿ LUER SLIP-TIP SYRINGE WITH ATTACHED NEEDLE PULLED OUT OF THE HUB DURING THE INJECTION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "WIFE INJECTS TESTOSTERONE 1MM SYRINGE CAPS ARE HARD TO REMOVE NEEDLE COMES OUT WITH IT. WENT TO REMOVE CAP AND NEEDLE CAME OUT. ALSO WHEN INJECTED HER HUSBAND THE NEEDLE POP OUT NEEDLE POPPED OFF NO INJURY TO HER HUSBAND. THE CAP TO THE NEEDLE IS ON TO STRONG. THE NEEDLE DID NOT COME OFF TILL SHE WENT TO INJECT IT."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17000976 ↗
• MalfunctionMar 4, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT THE NEEDLE OF THE BD¿ LUER SLIP-TIP SYRINGE WITH ATTACHED NEEDLE SEPARATED FROM THE HUB WHILE ASPIRATING MEDICINE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "NEEDLE SEPARATED FROM NEEDLE HUB WHILE DRAWING UP MEDICATION".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16483409 ↗
• MalfunctionMar 1, 2023Contamination; Contamination

  IT WAS REPORTED THAT PRIOR TO USE WITH 2 BD¿ LUER SLIP TIP SYRINGE WITH ATTACHED NEEDLE FOREIGN MATTER WAS DISCOVERED ON THE NEEDLE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: NEEDLES FOR INJECTIONS AT HOME BUT THEY ARE DIRTY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16464219 ↗
• MalfunctionFeb 23, 2023Physical Resistance/Sticking; Separation Problem; Physical Resistance/Sticking; Separation Problem

  IT WAS REPORTED THAT DURING USE WITH BD¿ LUER SLIP TIP SYRINGE WITH ATTACHED NEEDLE 25 G X 5/8 IN., STERILE THE NEEDLE PULLED OUT OF HUB AND THE PLUNGER WAS DIFFICULT TO PULL. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: VET SAID THE FOLLOWING: USING 1ML TB SYRINGE SLIP TIP 25GX 5/8 (309626) NEEDLES COME OFF SLIP TIP TOO EASILY. ALSO DOES NOT LIKE HOW EASY THE PLUNGER ROD PULLS BACK AND THEY LIKE A TOGETHER PULL FOR GREATER CONTROL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16432486 ↗
• MalfunctionNov 14, 2022Fungus in Device Environment; Fungus in Device Environment

  IT WAS REPORTED BY THE CUSTOMER THAT THE BD¿ LUER SLIP-TIP SYRINGE WITH ATTACHED NEEDLE EXPERIENCED MOLD ON PACKAGING. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER ADVISED 1 OUT OF 8 CS WAS MOLDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15794679 ↗
• MalfunctionNov 4, 2022Contamination; Contamination

  IT WAS REPORTED WHILE USING BD¿ LUER SLIP TIP SYRINGE WITH ATTACHED NEEDLE 25 G X 5/8 IN., STERILE MOLD WAS DISCOVERED. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE CUSTOMER CLAIMS THEY SEE MOLD ON THE PRODUCT UNIT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15739269 ↗
• MalfunctionOct 12, 2022Break; Break

  IT WAS REPORTED THAT THE NEEDLE OF THE BD¿ LUER SLIP-TIP SYRINGE WITH ATTACHED NEEDLE BROKE OFF INTO THE PATIENT'S ARM DURING THE MEDICINE ADMINISTRATION. NO FURTHER INFORMATION WAS PROVIDED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: :BD TB SYRINGES DO NOT HAVE SAFETY NEEDLE. NEEDLE CAN COME UNATTACHED DURING ADMINISTRATION OF MEDICATION. DURING ADMINISTRATION THE NEEDLE CAME OFF SYRINGE, LEAVING NEEDLE IN THE PATIENT ARM. THIS CAUSED AN INCREASED RISK OF STAFF NEEDLE STICK."

  Patient problems: Foreign Body In Patient

  MAUDE report 15587903 ↗
• MalfunctionOct 1, 2022Defective Device; Defective Device

  IT WAS REPORTED WHILE USING BD¿ LUER SLIP TIP SYRINGE WITH ATTACHED NEEDLE 25 G X 5/8 IN., STERILE THE SYRINGE SEPARATED FROM THE NEEDLE. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: SHE STATED THAT ONE SYRINGE SEPARATED BETWEEN THE HUB AND SYRINGE AS SHE WAS INJECTING HER DOG. CONSUMER WAS ABLE TO PULL THE NEEDLE HUB WITH NEEDLE ATTACHED FROM THE INJECTION SITE WITHOUT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15523658 ↗
• MalfunctionAug 29, 2022Defective Component; Defective Component

  IT WAS REPORTED THAT THE BD¿ LUER SLIP TIP SYRINGE EXPERIENCED THE PLUNGER NOT WORKING. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE PLUNGER DOES NOT WORK WELL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15314985 ↗
• MalfunctionJun 16, 2022Leak/Splash; Material Separation; Leak/Splash; Material Separation

  IT WAS REPORTED WHILE USING BD¿ LUER SLIP TIP SYRINGE WITH ATTACHED NEEDLE 25 G X 5/8 IN., STERILE THE NEEDLE WAS LOOSE AND PULLED OUT CAUSING LEAKAGE. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED BY THE CUSTOMER THE NEEDLES WON'T SAY ON THE SYRINGES. THE NEEDLES WON'T SAY ON THE SYRINGES. THEY POP OFF AN SPRAY MEDS EVERYWHERE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14716350 ↗

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-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-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-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