BD Micro-Fine 329461Recalls & reported problems

Summary

The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 30382903294610), received between Feb 2, 2018 and Mar 19, 2024 — classified as 1 injury, 18 malfunctions.

The most frequently reported specific device problem is “Device Contamination with Chemical or Other Material” (4 reports).

1 FDA recall record name this device's identifier, 1 still open.

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.

Recalls naming this device

1. Feb 1, 2023Open, Classified

   Nonsterile syringe potentially exposing the patient to pathogenic microorganisms and a risk of local infection.

   Z-1242-2023 · Root cause: Under Investigation by firm · FDA record ↗

Most reported problems

Recent adverse event reports

The 19 most recent of 19 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 19, 2024Device Markings/Labelling Problem; Device Markings/Labelling Problem

  ACCOUNT - MAYO CLINIC. MATERIAL DESCRIPTION - SYRINGE 0.5ML 28GA 1/2IN BLS 500CAS CA. MATERIAL# - 329461. MATERIAL LOT# - UNKNOWN. COMPLAINT - DUPLICATE UOU GTIN. THE INFORMATION PROVIDED SHOWS THAT EMBECTA MATERIAL NUMBER 329461 HAS THE SAME DEVICE ID UNIT OF USE NUMBER LIKE BD VACUTAINER MATERIAL NUMBER 367391. HI XXX, IT HAS BEEN A WHILE SINCE WE LAST SPOKE, I HOPE YOU ARE DOING WELL. I RECENTLY JOINED THE MAYO CLINIC TEAM (PREVIOUSLY (B)(6)) AND WAS NOT ABLE TO ATTEND THE LAST HTG MEETING YOU PRESENTED AT. XXX AND XXX SHARED THE SLIDES WITH ME TO BRING ME UP TO SPEED (VERY INFORMATIVE GREAT SLIDE DECK). I AM WORKING ON DATA CORRECTIONS WITHIN OUR PIM AND CAME ACROSS THE BELOW. COULD YOU PLEASE HELP ME UNDERSTAND THE DUPLICATE UOU GTIN, OR PROVIDE A GOOD CONTACT FOR ME TO WORK WITH ON THESE SORTS OF ISSUES ? THANKS IN ADVANCE!

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18938309 ↗
• MalfunctionOct 27, 2023Break; Break

  IT WAS REPORTED THAT WHILE USING THE BD ULTRA-FINE¿ INSULIN SYRINGE THE CANNULA BREAKS OFF. THE FOLLOWING WAS RECEIVED FROM THE INITIAL REPORTER: HE SAID ABOUT 1/3 OF THE SYRINGES HE HAD BEEN USING WERE EITHER BENDING OR BREAKING WHEN HE WAS TRYING TO INJECT THE INSULIN INTO HIS SKIN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18022773 ↗
• MalfunctionOct 13, 2023Material Deformation; Material Deformation

  IT WAS REPORTED THAT THE STOPPER IN THE BD INSULIN SYRINGE WITH THE BD MICRO-FINE¿ IV NEEDLE WAS DEFORMED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "DISTORTED STOPPER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17936489 ↗
• MalfunctionOct 4, 2022Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT 2 BD INSULIN SYRINGES WITH THE BD MICRO-FINE¿ IV NEEDLES EXPERIENCED FOREIGN MATTER WITHIN THE FLUID PATH. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: COTTON-LIKE MATTER RESIDUES STICK TO THE NEEDLE WHEN REMOVING THE PACKAGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15540170 ↗
• MalfunctionJul 9, 2021Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT 5 BD INSULIN SYRINGES WITH THE BD MICRO-FINE¿ IV NEEDLE HAD EXCESS SILICONE IN THE FLUID PATHWAY. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "I DON'T THINK THAT IT'S WATER, I BELIEVE IT TO BE EXCESS SILICONE OIL TO LUBRICATE THE SYRINGE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12147604 ↗
• MalfunctionJun 7, 2021Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT 5 BOXES OF BD INSULIN SYRINGES WITH THE BD MICRO-FINE¿ IV NEEDLE HAD FOREIGN LIQUID FOUND INSIDE THE SYRINGE BARRELS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THE END USER HAS STARTED USING THE SYRINGES AND NOTED THAT APPROXIMATELY 40% OF THE SYRINGES HAVE AN UNIDENTIFIED LIQUID IN THE SYRINGE. ALL FIVE BOXES HAVE THIS ISSUE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11949844 ↗
• MalfunctionDec 13, 2020Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT SYRINGE 0.5ML 28GA 1/2IN BLS 500CAS CA LEAKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 329461 BATCH NO: 0069680. IT WAS REPORTED THAT INSULIN CAME OUT OF THE END OF THE SYRINGE. VERBATIM: OUR CLIENT BOUGHT 60 BD SYRINGES. OF THE 60 HE ONLY HAD ABOUT 12 THAT WERE NOT FUNCTIONAL. INSULIN CAME OUT OF THE END OF THE SYRINGE. SO THE CLIENT LOST INSULIN AND ALSO SYRINGES DUE TO THIS BAD MANUFACTURING.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11000283 ↗
• MalfunctionApr 30, 2020Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT THE PACKAGE INFORMATION IS NOT CONSISTENT WITH SPECIFICATIONS REGISTERED IN LOCAL LICENSE WITH A BD SAFETY-LOK¿ INSULIN SYRINGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE CUSTOMER REPORTED THAT THE OD INFORMATION ON SHELF BOX AND PRIMARY PACKAGE SHOWS 28G (0.35MM) AND IS NOT CONSISTENT WITH THE SPECIFICATION REGISTERED IN LOCAL LICENSE, WHICH IS 28G (0.36MM). THE INCONSISTENCY IS CONSIDERED AS NON-COMPLIANCE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10016408 ↗
• MalfunctionApr 3, 2020Failure to Deliver; Failure to Deliver

  IT WAS REPORTED THAT AN UNSPECIFIED NUMBER OF SYRINGES 0.5ML 28GA 1/2IN BLS EXPERIENCED DIFFICULT PLUNGER MOVEMENT DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 329461 BATCH NO: 9028983. I AM A GRADUATE STUDENT IN OUR USER FACILITY. WE ORDERED SOME BOXES OF BD INSULIN SYRINGES (CAT#: 329461) A YEAR AGO, WHICH HAVE THE WRAPPED PACKAGES. A FEW DAYS AGO, THE SYRINGES WERE USED UP, SO WE ORDERED ANOTHER BULK OF BD INSULIN SYRINGES WITH THE SAME CAT#, WHICH HAVE THE WRAPPED PACKAGES. I USED A LOT OF THE SECOND BATCH OF SYRINGES AND FOUND THAT THEY ARE NOT AS SMOOTH AS THE SYRINGES IN THE FIRST BATCH FOR DOING IV INJECTIONS IN MICE. PER RESPONSE RECEIVED BY E-MAIL FROM THE CUSTOMER ON 03/19/2020: THANK YOU FOR YOUR QUICK REPLY! THE ANSWERS TO YOUR QUESTIONS ARE AS FOLLOWS: I HAVE THE LOT NUMBERS FOR BOTH SYRINGES: THE OLD BUT GOOD ONE IS 8301055, THE NEWLY ORDERED ONE IS 9028983, WHICH WE ORDERED FROM FISHER 6 MONTHS AGO. NO ONE WAS HURT. THE PROBLEM WITH THIS NEWLY BOUGHT NEEDLE IS THAT IT IS A LITTLE HARD TO PUSH THE SOLUTION INTO TAIL VEIN OF MICE, WHICH IS KIND OF HARD TO TELL WHETHER THE SOLUTION WENT TO THE TAIL VEIN OR IT WENT TO THE SUBC

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9924053 ↗
• InjuryJan 29, 2020Material Puncture/Hole; Material Protrusion/Extrusion; Material Puncture/Hole; Material Protrusion/Extrusion

  IT WAS REPORTED THAT THE SYRINGE 0.5ML 28GA 1/2IN BLS 500CAS CA EXPERIENCED THE NEEDLE PIERCING THROUGH THE SHIELD AFTER RE-CAPPING AND WAS INVOLVED IN A NEEDLE STICK INJURY TO THE HCP OR CARE GIVER AFTER USE. THE REPORTER STATED THAT AFTER THE NEEDLE HAD BEEN USED ON A PATIENT, THE NEEDLE PIERCED THROUGH THE CAP, AND STUCK THE HCP OR DEVICE OPERATOR. THE HCP/DEVICE OPERATORS RECEIVED TESTING FOR (B)(6). THE RESULTS OF THE TESTING HAVE NOT BEEN SPECIFIED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 329461, BATCH NO: 8337721. VERBATIM: THE CALLER STATED AFTER USING THE NEEDLE ON A PATIENT, THEY PUT THE CAP BACK ON THE NEEDLE AND THE NEEDLE WENT THROUGH THE CAP STICKING THE CALLER IN THE FINGER.

  Patient problems: Needle Stick/Puncture

  MAUDE report 9641004 ↗
• MalfunctionJan 21, 2020Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT SYRINGE 0.5ML 28GA 1/2IN BLS 500CAS CA PLUNGER ROD WAS DIFFICULT TO MOVE. THIS WAS DISCOVERED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 329461, BATCH NO: (B)(4). IT WAS REPORTED THAT THE PLUNGER ROD WAS DIFFICULT TO MOVE. EVENT DESCRIPTION PER EMAIL STATES: I HAVE AN ISSUE WITH SOME SYRINGES WE RECENTLY GOT IN. WE RECENTLY GOT THESE SYRINGES FOR BOTH BOXES. WE HAVE USED THE SIZE AND BRAND FREQUENTLY AND HAVE NEVER HAD THIS PROBLEM. THE PLUNGER WORKS REALLY HARD ON A HIGH PERCENTAGE OF THEM SUCH THAT IT IS REALLY NEARLY IMPOSSIBLE TO USE TO INJECT BECAUSE YOU HAVE TO PUSH WITH SUCH A FORCE WILL INJECTING INTO VERY YOUNG MICE. WE NORMALLY MOVE THE PLUNGER IN AND OUT A FEW TIMES BEFORE WE DRAW UP THE SOLUTION TOO SO THAT IS NOT THE ISSUE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9613399 ↗
• MalfunctionJan 14, 2020Leak/Splash; Failure to Deliver; Leak/Splash; Failure to Deliver

  IT WAS REPORTED THAT BD LO-DOSE¿ U-100 INSULIN SYRINGE WITH BD MICRO-FINE¿ IV NEEDLE PLUNGER ROD WAS DIFFICULT TO MOVE. THIS WAS DISCOVERED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 329461, BATCH NO: 9211307. IT WAS REPORTED THAT THE PLUNGER ROD WAS DIFFICULT TO MOVE. EVENT DESCRIPTION PER EMAIL STATES: I HAVE AN ISSUE WITH SOME SYRINGES WE RECENTLY GOT IN. WE RECENTLY GOT THESE SYRINGES. WE HAVE USED THE SIZE AND BRAND FREQUENTLY AND HAVE NEVER HAD THIS PROBLEM. THE PLUNGER WORKS REALLY HARD ON A HIGH PERCENTAGE OF THEM SUCH THAT IT IS REALLY NEARLY IMPOSSIBLE TO USE TO INJECT BECAUSE YOU HAVE TO PUSH WITH SUCH A FORCE WILL INJECTING INTO VERY YOUNG MICE. WE NORMALLY MOVE THE PLUNGER IN AND OUT A FEW TIMES BEFORE WE DRAW UP THE SOLUTION TOO SO THAT IS NOT THE ISSUE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9587169 ↗
• MalfunctionMay 31, 2019Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT A NEEDLE THROUGH CAP OCCURRED WITH A SYRINGE 0.5ML 28GA 1/2IN BLS 500CAS CA. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, "REAPPLIED CAP AFTER DRAWING UP INSULIN AND NEEDLE CAME THROUGH CAP AND NEEDLE STICK OCCURRED."

  Patient problems: Needle Stick/Puncture

  MAUDE report 8659955 ↗
• MalfunctionMay 7, 2019Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT THERE WERE 2 OCCURRENCES OF FOREIGN MATTER WITH A BD¿ SYRINGE 0.5ML 28GA 1/2IN BLS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: FOREIGN MATTER ON THE CANNULA.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8587873 ↗
• MalfunctionMay 2, 2019Volume Accuracy Problem; Volume Accuracy Problem

  IT WAS REPORTED THAT BD LOW-DOSE¿ U-100 INSULIN SYRINGE WITH BD MICRO-FINE¿ IV HAS SCALE MARKING ISSUES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO.: 329461 BATCH NO.: 8106971 THE BEVEL OF THE NEEDLE IS NOT ALIGNED WITH THE GRADUATION ON THE SYRINGE RESULTING IN DIFFICULTY WHEN DOING AN INJECTION WHEN THEY HAVE TO FOLLOW THE GRADUATION. ADDITIONALLY, CUSTOMER STATES THE WRAPPING HAS CHANGED. VERBATIM: I RECEIVED A COMPLAINT ABOUT THE SYRINGE 329461 SAYING THAT THE WRAPPING HAS CHANGE BUT MOST IMPORTANT IS THAT THE BEVEL OF THE NEEDLE IS NOT ALIGN WITH THE GRADUATION ON THE SYRINGE AND THAT IS HARDER TO DO INJECTION WHEN THEY HAVE TO FOLLOW THE GRADUATION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8575511 ↗
• MalfunctionMar 29, 2019Failure to Deliver; Failure to Deliver

  IT WAS REPORTED THAT THE NEEDLE OF BD¿ SYRINGE BLS 500CAS CA WERE BENT, AND THE MEDICATION COULD NOT BE PUSHED OUT. CUSTOMER¿S VERBATIM: THE TIPS OF THE NEEDLES ARE BENT AND THE MEDICATION CANNOT BE PUSHED OUT. SOME IN THE BOX ARE FINE AND OTHERS ARE NOT. THEY ARE HAVING TO OPEN A PACK, SEE IF IT IS BENT AND THEN THEY HAVE BEEN THROWING THEM AWAY IF THEY ARE. SO FAR THEY HAVE ONLY OPENED 2 BOXES OF THE 5 THEY ORDERED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8466392 ↗
• MalfunctionJun 5, 2018Crack; Device Damaged Prior to Use

  IT WAS REPORTED THAT THE BARREL ON A BD LOW-DOSE¿ U-100 INSULIN SYRINGE WITH BD MICRO-FINE¿ IV WAS FOUND BOWED/CRACKED PRIOR TO USE. THERE WAS NO REPORT OF EXPOSURE, SERIOUS INJURY, OR MEDICAL INTERVENTION.

  Patient problems: No Patient Involvement

  MAUDE report 7571139 ↗
• MalfunctionMar 19, 2018Delivered as Unsterile Product

  IT WAS REPORTED THAT DURING USE A BD LOW-DOSE¿ U-100 INSULIN SYRINGE WITH BD MICRO-FINE¿ IV PERMANENTLY ATTACHED NEEDLE WAS FOUND WITH A BREACH IN STERILE INTEGRITY. THERE WAS NO REPORT OF EXPOSURE, INJURY OR MEDICAL INTERVENTION NEEDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7349427 ↗
• MalfunctionFeb 2, 2018Physical Resistance

  IT WAS REPORTED THAT WHILE USING A BD LO-DOSE U-100 INSULIN SYRINGE WITH NEEDLE, TOO MUCH RESISTANCE WAS ENCOUNTERED WHEN PRESSING THE PLUNGER. THERE WAS NO REPORT OF INJURY OR MEDICAL INTERVENTION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7238196 ↗