BD Micro-Fine 329424Recalls & reported problems
Becton, Dickinson and Company Inc · BD Insulin Syringes with the BD Micro-Fine IV Needle, U-100, 12.7mm, 28G, 1mL, 2 units · Class 2
All models of BD Micro-Fine (6)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 12
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 30382903294245), received between Mar 26, 2018 and Aug 21, 2025 — classified as 12 malfunctions.
The most frequently reported specific device problem is “Material Puncture/Hole” (2 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Reports received per month
Recalls naming this device
- Feb 1, 2023Open, Classified
Nonsterile syringe potentially exposing the patient to pathogenic microorganisms and a risk of local infection.
Z-1239-2023 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
Most reported problems
Device problems
- Material Puncture/Hole2
- Packaging Problem2
- Delivered as Unsterile Product1
- Device Contamination with Chemical or Other Material1
- Device Damaged Prior to Use1
- Device Markings/Labelling Problem1
- Difficult or Delayed Positioning1
- Dull, Blunt1
Patient problems
- No Clinical Signs, Symptoms or Conditions4
- No Known Impact Or Consequence To Patient4
- Needle Stick/Puncture3
- No Consequences Or Impact To Patient2
- Hemorrhage/Blood Loss/Bleeding1
- Venipuncture1
Recent adverse event reports
The 12 most recent of 12 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 21, 2025Material Puncture/Hole; Material Puncture/Hole
ACCOUNT- (B)(6). SKU# UNKNOWN ITEM DESCRIPTION: BD INSULIN SYRINGE 1ML LOT# 3121576 QUANTITY- UNKNOWN. COUNTRY- USA INCIDENT DESCRIPTION- WE WANTED TO INFORM THE COMPANY THAT WE FOUND THIS BD INSULIN SYRINGE 1ML (LOT NO 3121576) WITH THE NEEDLE POKING THROUGH THE CAP. IT DID POKE ONE OF OUR ASSOCIATES. THE COMPANY MAY WANT TO INVESTIGATE INTO THIS. PLEASE CHECK THE ATTACHMENT FOR ADDITIONAL INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22868917 ↗MalfunctionJun 28, 2021Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
IT WAS REPORTED THAT THE SYRINGE 1.0ML 28GA 1/2IN BLS 500 BDD CA EXPERIENCED FOREIGN MATTER ON DEVICE CANNULA/IN FLUID PATH. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 329424; BATCH NO: 0218249. MANY SYRINGES HAVE FOREIGN PARTICULATES AND LOOK UNSTERILE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12076727 ↗MalfunctionMar 24, 2021Volume Accuracy Problem; Volume Accuracy Problem
IT WAS REPORTED THAT THE BD MICRO-FINEI¿ IV INSULIN SYRINGE HAD SCALE MARKING ISSUES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THERE ARE ONES WITH NO DOTS, ONE DOT AND TWO DOTS (SAME PACKAGING, GAUGE ETC)."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11565894 ↗MalfunctionJan 5, 2021Packaging Problem; Packaging Problem
IT WAS REPORTED THAT SEVERAL BD MICRO-FINE¿ IV INSULIN SYRINGES HAD ISSUES WITH PARTIAL UNSEALED PACKAGING UNITS. THERE WERE 3 FROM LOT 9119537, 14 FROM 9140521, 18 FROM 9168926, 30 FROM 9189788, 25 FROM 9196270, 5 FROM 9231122, 1 FROM 9287332, 38 FROM 9294983, 15 FROM 0099954, 256 FROM 0160417, 23 FROM 8302667, 36 FROM 8351757, AND 3 FROM 9322637. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "ITEM 329424, A TOTAL OF 467 UNITS ACROSS 13 LOT NUMBERS WERE FOUND TO BE PARTLY UNSEALED"
Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient
MAUDE report 11121460 ↗MalfunctionOct 20, 2020Material Puncture/Hole; Material Puncture/Hole
IT WAS REPORTED THAT A BD SYRINGE 1.0ML 28GA 1/2IN BLS 500 BDD CA HAD THE NEEDLE PUNCTURE THROUGH THE SHIELD BEFORE USE. THE FOLLOWING WAS REPORTED BY THE INITIAL REPORTER: "IT WAS REPORTED THAT NEEDLE WAS BENT AND WENT THROUGH NEEDLE SHIELD WHICH CAUSED A STAFF MEMBER TO HAVE A NEEDLE STICK. VERBATIM: NEEDLE WAS BENT AND POKED THROUGH THE CAP. ONE STAFF MEMBER GOT A SLIGHT NEEDLE POKE."
Patient problems: Needle Stick/Puncture
MAUDE report 10709038 ↗MalfunctionOct 7, 2020Difficult or Delayed Positioning; Difficult or Delayed Positioning
IT WAS REPORTED THAT SYRINGE 1.0ML 28GA 1/2IN BLS 500 BDD CA NEEDLE TIPS WERE BLUNT OR HAD A HOOK AND DAMAGED THE PATIENT'S VEINS. THIS WAS DISCOVERED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO. 329424, BATCH NO. 7044539/0013361/9168928. IT WAS REPORTED THAT NEEDLE TIPS ARE BLUNT OR HAVE A HOOK AT THE END, AND HAS VISIBLE SCABBING AND HAS DAMAGED HIS VEINS. VERBATIM: WE HAVE HAD A COMPLAINT FROM A HR CLIENT. HE SAYS THAT THE LAST 3 BOXES OF 1CC SYRINGES, THE NEEDLE TIPS HAVE A FINE BLUNTING OR HOOK ON THE END. HE SAID ONLY ~10 WERE "GOOD" IN EACH BOX.. PLEASE NOTE THAT THE CUSTOMER HAS VISIBLE SCABBING AND HAS DAMAGED HIS VEINS DUE TO THIS PRODUCT ISSUE.
Patient problems: Needle Stick/Puncture; Venipuncture
MAUDE report 10640244 ↗MalfunctionJun 8, 2020Device Markings/Labelling Problem; Device Markings/Labelling Problem
IT WAS REPORTED THAT THE BOX OF BD MICRO-FINEI¿ IV INSULIN SYRINGES HAD NO EXPIRATION DATE PRINTED ON IT. THIS WAS NOTICED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "PHARMACIST STATED SHE HAS 5 -6 BOXES OF THE BD INSULIN SYRINGES, ALL WITH THE SAME LOT # AND CATALOG # AND NONE OF THEM HAVE EXPIRATION DATES ON THEM. STATED SHE PROVIDED A CONSUMER WITH ONE BOX OF THESE SYRINGES AND THE CONSUMER RETURNED IT, STATING HE DID NOT WANT TO USE THIS BOX BECAUSE HE LOOKED THE PRODUCT UP ONLINE AND HE BELIEVES THEY EXPIRED IN 2016. ADVISED PHARMACIST OF HOW BD DETERMINES THE EXPIRATION DATE USING THE COPYRIGHT DATE, THE LOT # AND JULIAN DATE. PHARMACIST STATED THERE IS NO COPYRIGHT/TRADEMARK DATE OR MANUFACTURE DATE ON ANY OF THE BOXES. ADVISED PHARMACIST THAT THE LOT # MEANS THIS BOX WAS EITHER MANUFACTURED IN 2006 EXPIRING IN 2011 OR 2016 EXPIRING IN 2021."
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10131056 ↗MalfunctionAug 26, 2019Delivered as Unsterile Product; Delivered as Unsterile Product
IT WAS REPORTED THAT BD MICRO-FINE¿ INSULIN SYRINGE CAPS WERE OFF. THIS OCCURRED ON 3 OCCASIONS BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 329424 BATCH NO: UNKNOWN (PROVIDED 8316939) IT WAS REPORTED PICKED UP THE PACKAGE AND NEEDLES STUCK HER CAUSING BLEEDING. (3 CAPS WERE OFF THE SEALED BAG OF SYRINGES). VERBATIM: PATIENT WAS BUYING A 10 PK OF NEEDLES. PICKED UP THE PACKAGE AND NEEDLES STUCK HER CAUSING BLEEDING. (3 CAPS WERE OFF THE SEALED BAG OF SYRINGES). _____(RPH) TOOK THE PATIENT INTO THE IMMUNIZATION AND CLEANED HER UP. PATIENT IS FINE. WE CHECKED THE OTHER BAGS INSIDE THIS BOX AND FOUND 2 OTHERS THAT HAD SOME LIDS THAT COME OFF. -SOC NOTIFIED.
Patient problems: Hemorrhage/Blood Loss/Bleeding; Needle Stick/Puncture
MAUDE report 8931889 ↗MalfunctionMar 21, 2019Device Damaged Prior to Use; Failure to Deliver; Device Damaged Prior to Use; Failure to Deliver
THE FOLLOWING WAS REPORTED FOR SYRINGE 1.0ML 28GA 1/2IN BLS 500 BDD CA, " IT WAS REPORTED THAT FOUR NEEDLES HAD A SPLIT TIP, ONE NEEDLE WAS UNABLE TO PASS FLUID WHEN THE PLUNGER WAS DEPRESSED AND THERE WERE OTHERS THAT WERE BENT. VERBATIM: TESTED 10 RIGS FROM LOT, FOUND 5 DAMAGED - 4 W/ SPLIT TIP, 1 UNABLE TO PASS FLUID WHEN PLUNGER DEPRESSED. ANOTHER USER STATED THEY HAD QUITE A FEW DAMAGED OR BENT - THE ONE HE HAD HIS SHOT IN WAS SO DAMAGED, THAT I HAD TO REMOVE THE PLUNGER AND TURN THE RIG UPSIDE TO GET THE DRUGS/LIQUID OUT, BECAUSE NOTHING WOULD COME OUT OF THE NEEDLE TIP."
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8440452 ↗MalfunctionDec 26, 2018Packaging Problem; Packaging Problem
IT WAS REPORTED THAT "A HAIR WAS LAMINATED IN THE SEAL" OF THE BD MICRO-FINE¿ IV INSULIN SYRINGE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8197802 ↗MalfunctionAug 14, 2018Tear, Rip or Hole in Device Packaging; Material Twisted/Bent
IT WAS REPORTED THAT BD MICRO-FINE¿ IV INSULIN SYRINGE HAD A BREACH IN THE STERILE BARRIER BECAUSE A NEEDLE WAS BENT AND PIERCED THE PACKAGING. NO SERIOUS INJURY, EXPOSURE OF BLOOD BORNE PATHOGENS TO MUCOUS MEMBRANE, OR MEDICAL INTERVENTION WAS REPORTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7781744 ↗MalfunctionMar 26, 2018Material Too Rigid or Stiff; Dull, Blunt
IT WAS REPORTED THAT THE NEEDLE ON A BD MICRO-FINE¿ IV INSULIN SYRINGE WAS BARBED, CAUSING DAMAGE TO VEINS AND THERE WERE A FEW PEOPLE WHO DEVELOPED ABSCESSES AFTER INJECTION. IT WAS ALSO REPORTED THAT THE PLUNGER ON THE SYRINGE WAS STIFF AND DIFFICULT TO MOVE. THERE WAS NO REPORT OF MEDICAL INTERVENTIONS.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7370950 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026 · each recall links to the FDA recall notice
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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