BD Micro-Fine 329420Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 30382903294207), received between Feb 5, 2018 and Sep 9, 2026 — classified as 1 injury, 11 malfunctions.

The most frequently reported specific device problem is “Break” (7 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-1238-2023 · Root cause: Under Investigation by firm · FDA record ↗

Most reported problems

Recent adverse event reports

The 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 9, 2026Material Puncture/Hole

  Patient problems: Needle Stick/Puncture

  MAUDE report 50697351 ↗
• MalfunctionNov 5, 2024Material Puncture/Hole; Material Puncture/Hole

  MATERIAL # 329420 MATERIAL DESCRIPTION - SYRINGE 1.0ML 28GA 1/2IN BLS 500 SUS CA MATERIAL LOT# - 3107277 COMPLAINT DESCRIPTION ¿ AS PER ACCOUNT, THE CUSTOMER HAD 2 INCIDENTS OF NEEDLES POKING OUT. ONE OF THEIR NURSES GOT POKED BUT IS THANKFULLY OKAY. NOTES ¿ IMAGES ATTACHED FOR REFERENCE PROVIDED BY CUSTOMER.

  Patient problems: Needle Stick/Puncture

  MAUDE report 20614578 ↗
• MalfunctionApr 28, 2021Break; Leak/Splash; Break; Leak/Splash

  IT WAS REPORTED THAT A SYRINGE 1.0ML 28GA 1/2IN BLS 500 SUS CA WAS FOUND TO BE DAMAGED DURING USE. THE FOLLOWING WAS REPORTED BY THE INITIAL REPORTER: "IT WAS REPORTED THAT PLUNGER ROD IS DIFFICULT TO MOVE AND VEINS ARE BLOWING UP. THIS CAUSES PAIN TO THE PATIENT. VERBATIM: FROM PHONE CALL ON (B)(6) 2021 16:57:37: CONSUMER STATED, PLUNGER IS HARD TO PUSH ON WHEN TAKING INJECTIONS. STATED, IT GETS "STUCK", CAUSING HER TO PUSH HARDER AND AS RESULT, SHE EXPERIENCES PAIN IN HER "VEINS".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11737018 ↗
• MalfunctionApr 28, 2021Mechanical Problem; Use of Device Problem; Positioning Problem; Physical Resistance/Sticking

  MATERIAL NO. 329420 BATCH NO. 0262090. IT WAS REPORTED THAT PLUNGER ROD IS DIFFICULT TO MOVE AND VEINS ARE BLOWING UP. THIS CAUSES PAIN TO THE PATIENT. VERBATIM: FROM PHONE CALL ON 2021-04-06 16:57:37: CONSUMER STATED, PLUNGER IS HARD TO PUSH ON WHEN TAKING INJECTIONS. STATED, IT GETS "STUCK", CAUSING HER TO PUSH HARDER AND AS RESULT, SHE EXPERIENCES PAIN IN HER "VEINS".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11735994 ↗
• MalfunctionMay 7, 2020Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT SYRINGE 1.0ML 28GA 1/2IN BLS 500 SUS CA PLUNGER ROD IS DIFFICULT TO MOVE. THIS WAS DISCOVERED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO. 329420 BATCH NO. UNKNOWN. IT WAS REPORTED THAT SYRINGES STICK AND ARE VERY HARD TO PRESS, LEAVING VEINS ALL BLOWN UP. ALSO REPORTED BUMPS BECAUSE SYRINGE IS STICKING IN SKIN.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10033237 ↗
• InjuryApr 14, 2020Defective Device; Defective Device

  IT WAS REPORTED THAT SYRINGE 1.0ML 28GA 1/2IN BLS 500 SUS CA NEEDLE SEPARATED FROM THE HUB AND PATIENT WENT TO THE ER AND RECEIVED X-RAYS TO DETERMINE IF THE NEEDLE REMAINED IN HIS ARM. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "IT WAS REPORTED THAT AFTER THE INJECTION THE PATIENT AND PERSON ADMINISTERING NOTED THAT THE NEEDLE WAS MISSING. AFTER GOING TO THE ER AND HAVING AN X-RAY PERFORMED, IT WAS CONFIRMED THAT NO NEEDLE WAS PRESENT IN THE PATIENT'S ARM. THE SYRINGE WAS X-RAYED AND IT INDICATED THAT THE NEEDLE WAS IN THE BARREL OF THE SYRINGE. "

  Patient problems: No Code Available

  MAUDE report 9960122 ↗
• MalfunctionAug 23, 2019Break; Break

  IT WAS REPORTED THAT A NEEDLE BREAK OCCURRED DURING USE WITH A SYRINGE 1.0 ML 28GA 1/2 IN BLS 500 SUS CA. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, "CUSTOMER IS STATING THEY NO LONGER CAN USE AND ALSO THAT THE NEEDLES ARE BREAKING. I DON'T KNOW IF THEY REPORTED THE ISSUE BUT THEY WON'T USE AND WE DON'T HAVE ANY OTHER CUSTOMERS THAT USE THIS PRODUCT. 300 CASES. 105 CASES. ITEM #329420 LOT AND EXPIRATION: LOT #8337907 EXPIRATION IS 2-29-2024, LOT #7079902 EXPIRATION IS 4-30-2022, LOT #8183955 EXPIRATION IS 9-30-2023, LOT #8169595 EXPIRATION IS 9-30-2023."

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8925456 ↗
• MalfunctionAug 22, 2019Break; Break

  MATERIAL NO. 329420, BATCH NO. 8337907,7079902,8183955,8169595. IT WAS REPORTED THAT DURING USE OF THE BD MICRO-FINE¿ IV INSULIN SYRINGE THE NEEDLES ARE BREAKING. THE DISTRIBUTOR PROVIDED FOUR DIFFERENT LOT NUMBERS: 8337907, 7079902, 8183955, AND 8169595. CUSTOMER PROVIDED THREE DATES: THIS COMPLAINT CAPTURES (B)(6) 2019. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER IS STATING THEY NO LONGER CAN USE AND ALSO THAT THE NEEDLES ARE BREAKING. I DON'T KNOW IF THEY REPORTED THE ISSUE BUT THEY WON'T USE AND WE DON'T HAVE ANY OTHER CUSTOMERS THAT USE THIS PRODUCT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8921800 ↗
• MalfunctionAug 5, 2019Break; Break

  MATERIAL NO. 329420 BATCH NO. UNKNOWN (PROVIDED 8337907,7079902,8183955,8169595). IT WAS REPORTED THAT DURING USE OF THE BD MICRO-FINE¿ IV INSULIN SYRINGE THE NEEDLES ARE BREAKING. THE DISTRIBUTOR PROVIDED FOUR DIFFERENT LOT NUMBERS, BUT THE ACTUAL LOT NUMBER IS UNKNOWN. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER IS STATING THEY NO LONGER CAN USE AND ALSO THAT THE NEEDLES ARE BREAKING. I DON'T KNOW IF THEY REPORTED THE ISSUE BUT THEY WON'T USE AND WE DON'T HAVE ANY OTHER CUSTOMERS THAT USE THIS PRODUCT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8859268 ↗
• MalfunctionMar 7, 2019Break; Break

  IT WAS REPORTED THAT DURING USE OF THE BD MICRO-FINE¿ IV INSULIN SYRINGE THAT THE NEEDLES BREAK OR "CROOKS" WHEN INJECTING INTO THE SKIN OR WHEN RECAPPING THE NEEDLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8401471 ↗
• MalfunctionDec 3, 2018Break; Break

  IT WAS REPORTED WITH THE USE OF THE BD MICRO-FINE¿ IV INSULIN SYRINGE THERE WAS AN ISSUE WITH NEEDLES BREAKING DURING INJECTION OR WHEN RECAPPING.

  Patient problems: No Information

  MAUDE report 8126730 ↗
• MalfunctionFeb 5, 2018Break

  IT WAS REPORTED WITH THE USE OF THE BD MICRO-FINE¿ IV INSULIN SYRINGE THE NEEDLE TIPS WERE BREAKING. NO REPORT OF ADDITIONAL INFORMATION. THERE WAS NO REPORT OF INJURY OR MEDICAL INTERVENTION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7242465 ↗