BD Ultra-Fine 328431Recalls & reported problems

Summary

The FDA's MAUDE database contains 78 adverse event reports that list this exact device (DI 00382908431033), received between Nov 27, 2017 and Sep 25, 2026 — classified as 1 injury, 77 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (28 reports).

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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 78 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 25, 2026Device Contamination with Chemical or Other Material

  Consumer reported that there is a black streak on the barrel of 2 syringes. The syringes and packaging have been discarded. Consumer was not able to provide the lot #.Lot #: UnknownCatalog #: 328431Date of Event: unknownSamples: discarded

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50900090 ↗
• MalfunctionNov 12, 2024Failure to Deliver; Failure to Deliver

  CONSUMER REPORTED THAT THE PLUNGER ROD IS NOT DRAWING THE INSULIN. LOT #: 3352105, CATALOG #: 328431, DATE OF EVENT: UNKNOWN, SAMPLES: AVAILABLE - SENDING MAIL KIT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20664339 ↗
• MalfunctionNov 11, 2024Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  CONSUMER REPORTED THAT THERE IS A BLACK STREAK ON THE BARREL OF 2 SYRINGES. THE SYRINGES AND PACKAGING HAVE BEEN DISCARDED. CONSUMER WAS NOT ABLE TO PROVIDE THE LOT #. LOT #: UNKNOWN, CATALOG #: 328431, DATE OF EVENT: UNKNOWN, SAMPLES: DISCARDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20652956 ↗
• MalfunctionSep 24, 2024Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  MATERIAL # 328431. MATERIAL DESCRIPTION - SYRINGE 0.3ML 30GA 1/2IN UF 10BAG 500CS. MATERIAL LOT# - 3282486. COMPLAINT DESCRIPTION ¿ A CLINIC THAT ONE OUR DISTRIBUTORS HAVE SOLD THE 328431 SYRINGE 0.3ML 30X1/2 ULTRA-FINE LOT# 3282486 - SAYING THAT THEY NOTICED THAT TWO OR THREE OUT OF EACH BAG HAD A VERY CLEAR YELLOW HUE. (IT LOOKS LIKE THE PLUNGER PORTION IS YELLOW). NOTE: PICTURE ATTACHED FOR FURTHER REFERENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20293927 ↗
• MalfunctionJun 13, 2024Device Markings/Labelling Problem; Device Markings/Labelling Problem

  PHARMACY REPORTED FOUND 3 BOXES OF PRODUCT BELIEVE TO BE EXPIRED. BUT NO EXP DATE ON THE BOX FOUND. FROM INFORMATION RECEIVED, LOT # AND ITEM NUMBER PLUS COPY DATE, ITEM IS EXPIRED. DC. LOT # 7296753. CATALOG# 328431. DATE OF EVENT 05.22.2024. SAMPLE STATUS DISCARDING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19533322 ↗
• MalfunctionSep 19, 2023Material Separation; Material Separation

  IT WAS REPORTED WHILE USING BD INSULIN SYRINGES WITH BD ULTRA-FINE¿ NEEDLE THE HUB SEPARATED FROM THE DEVICE. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CONSUMER REPORTED FOUND 2 SYRINGES WHEN REMOVED NEEDLE SHIELD THE HUB ASSEMBLY STAYED IN THE SHIELD. LOT # 0160994. CATALOG# 328431. DATE OF EVENT UNKNOWN THIS BOX . SAMPLE STATUS AWAITING SAMPLE 1 OUT OF THE 2 SAMPLES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17773967 ↗
• MalfunctionMay 8, 2023Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT THE SCALE MARKINGS ON THE BD INSULIN SYRINGE WITH THE BD ULTRA-FINE¿ NEEDLE BARREL WERE THICKER, MAKING IT DIFFICULT TO READ THEM AND SEE THE INSULIN INSIDE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "CONSUMER REPORTED FONT ON THE BARREL OF SYRINGE SEEMS BOLDER / THICKER, MAKES IT HARDER TO SEE IF INSULIN HAS BUBBLES IN INSULIN OR NOT. YOU CAN'T SEE AROUND THE MARKINGS. THIS BOX ONLY."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16891847 ↗
• MalfunctionSep 20, 2022Failure to Deliver; Failure to Deliver

  IT WAS REPORTED THAT THE BD INSULIN SYRINGES WITH BD ULTRA-FINE¿ NEEDLE WILL NOT DRAW. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CONSUMER REPORTED THAT THE NEEDLE WILL NOT DRAW, STATED THAT THE PLUNGER ROD GOES BACK WHEN HE INSERTS IT INTO THE VIAL. THIS COMPLAINT WAS PREVIOUSLY REPORTED ON CASE FILE CS0061270, CONSUMER HAD SAME ISSUE WITH ADDITIONAL SYRINGES FROM THE SAME BOX AND LOT #. CONSUMER REQUESTED MAIL KIT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15459257 ↗
• MalfunctionAug 8, 2022Break; Break

  IT WAS REPORTED THAT WHILE USING A BD INSULIN SYRINGES WITH BD ULTRA-FINE¿ NEEDLE 3/10ML 12.7MM (1/2") 30G U-100 100 COUNT, THE NEEDLE BREAKS OFF IN THE VIAL. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "NEEDLES ARE FALLING OUT OF SYRINGES". CONSUMER STATED, WHEN DRAWING INSULIN, THE NEEDLE ONLY, WILL BREAK OFF IN VIAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15187815 ↗
• MalfunctionJul 6, 2022Material Separation; Material Separation

  IT WAS REPORTED WHILE USING BD INSULIN SYRINGES WITH BD ULTRA-FINE¿ NEEDLE THAT WHEN PLUNGER CAP IS REMOVED, THE PLUNGER ROD FALLS OUT OF THE SYRINGE AND STAYS IN THE PLUNGER CAP. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CONSUMER / PET OWNER REPORTED PLUNGER CAP HARD TO REMOVE - WHEN REMOVED THE PLUNGER ROD FALLS OUT OF SYRINGE AND STAYS IN THE PLUNGER CAP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14937806 ↗
• MalfunctionFeb 17, 2022Material Deformation; Material Deformation

  IT WAS REPORTED THAT 4 BD INSULIN SYRINGES WITH BD ULTRA-FINE¿ NEEDLES EXPERIENCED DEFORMED STOPPERS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: PET OWNER REPORTED DAMAGED STOPPER, 4 SYRINGES WERE AFFECTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13551185 ↗
• MalfunctionDec 9, 2021Partial Blockage; Partial Blockage

  IT WAS REPORTED THAT THE BD ULTRA-FINE¿ INSULIN SYRINGES 3/10ML EXPERIENCED DIFFICULT PLUNGER MOVEMENT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ALSO REPORTED PLUNGER ROD DIFFICULT TO MOVE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12973063 ↗
• MalfunctionJul 20, 2021Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT 3 BD ULTRA-FINE¿ INSULIN SYRINGES 3/10ML EXPERIENCED MISSING LABEL INFORMATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: PHARMACIST REQUESTED ASSISTANCE LOCATING EXPIRATION DATE ON BOX. STATED, IT WAS MISSING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12198569 ↗
• MalfunctionMay 11, 2021Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT A SYRINGE 0.3ML 30GA 1/2IN UF 10BAG 500CS SEPARATED FROM THE HUB DURING USE. THE FOLLOWING WAS REPORTED BY THE INITIAL REPORTER: "IT WAS REPORTED THAT WHEN NEEDLE SHIELD WAS REMOVED THE NEEDLE HUB SEPARATED INTO IT. VERBATIM: PET OWNER REPORTED, WHEN SHE REMOVED NEEDLE SHIELD, NEEDLE HUB SEPARATED 1 SYRINGE AFFECTED".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11809586 ↗
• MalfunctionApr 28, 2021Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT BD ULTRA-FINE¿ INSULIN SYRINGES 3/10ML EXPERIENCED A CASE OF A PLUNGER THAT WAS LOOSE/FELL OUT/SEPARATED, AND A CASE OF HUB SEPARATION FROM THE DEVICE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CONSUMER REPORTED PLUNGER CAP WAS DIFFICULT TO REMOVE. PLUNGER ROD DETACHED FROM SYRINGE. NEEDLE HUB SEPARATED AND WAS STUCK INSIDE OF THE SHIELD. LOT #: 1077626. CATALOG #: 328431. DATE OF EVENT: UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11742906 ↗
• MalfunctionApr 28, 2021Leak/Splash; Failure to Deliver; Defective Device; Leak/Splash; Failure to Deliver; Defective Device

  IT WAS REPORTED THAT BD ULTRA-FINE¿ INSULIN SYRINGES 3/10ML EXPERIENCED A CASE OF DIFFICULT PLUNGER MOVEMENT, A PLUNGER THAT WAS LOOSE/FELL OUT/SEPARATED, AND PRODUCT DAMAGE/DEFORMATION WHILE STILL CONSIDERED OPERABLE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 328431, BATCH NO: 0335562, AWFUL LOT OF SYRINGES 3ML- FOUND WITH MULTIPLE DEFECTS, SEEMS LIKE IT WAS VERY DIFFICULT TO PUSH THESE SYRINGES. ONE HAD THE CAP WAS OFF/DEFECTIVE. A SYRINGE HAD A LOOSE PART.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11740736 ↗
• MalfunctionApr 28, 2021Volume Accuracy Problem; Volume Accuracy Problem

  IT WAS REPORTED THAT THE BD ULTRA-FINE¿ INSULIN SYRINGES 3/10ML EXPERIENCED SCALE MARKING ISSUES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 328431 BATCH NO: 0335562. AWFUL LOT OF SYRINGES 3ML- FOUND WITH MULTIPLE DEFECTS, THE SYRINGE MEASUREMENT SETTINGS WERE OFF/ NOT ACCURATE DEFECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11739704 ↗
• MalfunctionApr 26, 2021Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT 6 SYRINGE 0.3ML 30GA 1/2IN UF 10BAG 500CS SEPARATED FROM THE HUB DURING USE. THE FOLLOWING WAS REPORTED BY THE INITIAL REPORTER: "IT WAS REPORTED THAT NEEDLE HUB SEPARATED ON 6 SYRINGES. VERBATIM: CONSUMER REPORTED, WHEN HE REMOVED NEEDLE SHIELD, NEEDLE HUB SEPARATED".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11729702 ↗
• MalfunctionApr 1, 2021Volume Accuracy Problem; Volume Accuracy Problem

  IT WAS REPORTED THAT AN UNSPECIFIED NUMBER OF SYRINGE 0.3ML 30GA 1/2IN UF 10BAG 500CS HAD MISSING SCALE MARKINGS BEFORE USE. THE FOLLOWING WAS REPORTED BY THE INITIAL REPORTER: "IT WAS REPORTED THE UNIT MARKING UNUSABLE ON A FEW OF THE SYRINGES. VERBATIM: EMAIL:HI I'M A TYPE 1 DIABETIC AND I HAVE USED YOUR BD SYRINGES FOR YEARS. I FOUND AN ISSUE WITH A FEW SYRINGES WITH THE UNIT MARKING UNUSABLE ON A FEW OF THE SYRINGES. JUST WANTED TO LET YOU KNOW. PRODUCT NAME AND/OR CATALOG NUMBER - BD INSULIN SYRINGES 3/10 ML 12.7MM / 30G ( ULTRAFINE) LOT NUMBER OR SERIAL NUMBER - 0111971 ANY INJURIES AND/OR HARM? - NO. WHAT IS THE ISSUE YOU EXPERIENCED? - THE INSULIN SYRINGES DID NOT HAVE MARKINGS USABLE FOR DRAWING THE CORRECT AMOUNT ( OF INSULIN) . I'LL ATTACH PICS. IS THE ACTUAL SAMPLE OR SAMPLE REPRESENTATIVE AVAILABLE? (IF POSSIBLE, PLEASE SEND AFFECTED SAMPLE) - I SAVED ONE FOR YOU IF NEEDED. THANKS FOR YOUR ASSISTANCE WITH THIS!"

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11606035 ↗
• MalfunctionMar 29, 2021Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT 5 SYRINGES 0.3ML 30GA 1/2IN UF EXPERIENCED HUB SEPARATION FROM THE DEVICE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CONSUMER REPORTED WHEN REMOVING NEEDLE SHIELDS, NEEDLE ASSEMBLY MISSING ON 5 SYRINGES. THESE SAME 5 SYRINGES WERE HARD TO REMOVE THE NEEDLE SHIELDS. LOT #: 0055954A. CATALOG#: 328431.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11585778 ↗
• MalfunctionMar 23, 2021Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT 2 BD ULTRA-FINE¿ INSULIN SYRINGES 3/10ML EXPERIENCED HUB SEPARATION FROM THE DEVICE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CONSUMER REPORTED, WHEN HE REMOVED NEEDLE SHIELD, NEEDLE HUB SEPARATED. STATED, 2 AFFECTED LAST NIGHT, ((B)(6) 2021) BUT ITS HAPPENED MORE THAN TWICE FROM BOX HE IS REPORTING. LOT: 0055954, CATALOG: 328431, DATE OF EVENT: (B)(6) 2021.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11558658 ↗
• MalfunctionMar 20, 2021Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT A SYRINGE 0.3ML 30GA 1/2IN UF 10BAG 500CS SEPARATED FROM THE HUB DURING USE. THE FOLLOWING WAS REPORTED BY THE INITIAL REPORTER: "IT WAS REPORTED THAT HUB SEPARATED WITH NEEDLE. VERBATIM: CONSUMER REPORTED WHEN REMOVING THE ORANGE NEEDLE SHIELD THE WHOLE NEEDLE COMPONENT COMES OFF WITH IT. STATED THIS HAPPENED WITH TWO SYRINGES. "

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11533159 ↗
• MalfunctionMar 20, 2021Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT A SYRINGE 0.3ML 30GA 1/2IN UF 10BAG 500CS SEPARATED FROM THE HUB DURING USE. THE FOLLOWING WAS REPORTED BY THE INITIAL REPORTER: "IT WAS REPORTED THAT HUB SEPARATED WITH NEEDLE. VERBATIM: CONSUMER REPORTED WHEN REMOVING THE ORANGE NEEDLE SHIELD THE WHOLE NEEDLE COMPONENT COMES OFF WITH IT. STATED THIS HAPPENED WITH TWO SYRINGES."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11533113 ↗
• MalfunctionMar 7, 2021Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT AN UNSPECIFIED NUMBER OF SYRINGE 0.3ML 30GA 1/2IN UF 10BAG 500CS SEPARATED FROM THE HUB DURING USE. THE FOLLOWING WAS REPORTED BY THE INITIAL REPORTER: "IT WAS REPORTED THAT NEEDLE HUB SEPARATES INTO SHIELD. VERBATIM: CONSUMER REPORTED WHEN REMOVING THE ORANGE NEEDLE SHIELD THE NEEDLE IS COMING OFF AND STAYING IN THE NEEDLE SHIELD. CONSUMER STATED THIS HAS HAPPENED WITH 1-2 SYRINGES FROM EACH POLY BAG."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11427518 ↗
• MalfunctionNov 25, 2020Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT THE BD ULTRA-FINE¿ INSULIN SYRINGES 3/10ML EXPERIENCED A MIX OF PRODUCT TYPES IN A PACK. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CONSUMER REPORTED THAT THERE WERE DIFFERENT SIZE SYRINGES MIXED IN THE SEALED BAGS. SHE SAID SHE PURCHASED 12.7MM SYRINGES, BUT NOTICED THAT SOME OF THE SYRINGES HAD MUCH SHORTER NEEDLES. SHE ALSO STATED THAT HER PHARMACIST GIVES HER BAGS AT A TIME INSTEAD OF A FULL BOX, AND SEVERAL BAGS HAD TWO DIFFERENT SYRINGES INSIDE OF THE BAG. CONSUMER REQUESTED THE MAIL KIT, BUT STATED THAT SHE MAY NOT SEND SAMPLES IN, SHE SAID SHE WILL SPEAK WITH HER PHARMACIST FIRST. LOT #: 0160994; CATALOG #: 328431; DATE OF EVENT: UNKNOWN.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10901652 ↗