BD Safety-Lok 309592Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 30382903095927), received between May 18, 2018 and Apr 12, 2024 — classified as 9 malfunctions.

The most frequently reported specific device problem is “Device Contamination with Chemical or Other Material” (2 reports).

1 other recall cover devices cleared under the same FDA submission (K944757); 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. 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 12, 2024Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT THE BD SAFETY-LOK HAD FOREIGN MATTER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "3CC SYRINGES HAVE BLACK PIECES." VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. MEDLINE COMPLAINT #: (B)(4). DEFECT DESCRIPTION: 3CC SYRINGES HAVE BLACK PIECES. MEDLINE PART #: (B)(4). PRODUCT DESCRIPTION: SYR 3ML L/L. VENDOR PART #: 301073 LOT #: UNKNOWN DATE REPORTED: (B)(6) 2024 SAMPLE RECEIVED: YES. RESPONSE NEEDED: SUMMARY OF FINDINGS AND CORRECTIVE ACTION. COMPLAINT REPORTED TO FDA AS MDR-30 DAY. REFERENCE NO. (B)(4). ADDITIONAL INFORMATION PROVIDED ON 03/27/2024: PLEASE PROVIDE THE BATCH# NUMBER? UNKNOWN. KINDLY PROVIDE THE ADDRESS OF THE FACILITY FOR US TO SHIP THE RETURN LABEL. NO SAMPLE AVAILABLE. DID THE EVENT DIRECTLY, OR INDIRECTLY INVOLVE A PATIENT OR USER? NO PATIENT INVOLVEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19095356 ↗
• MalfunctionDec 29, 2020Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE NEEDLE HUB SEPARATED FROM THE SYRINGE SAFETYLOK 3ML LL W/NDL 25X5/8 WHILE REMOVING THE SHIELD. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "CONSUMER REPORTED, PHARMACY REFILLED HER PRESCRIPTION WITH THE WRONG SYRINGES. STATED, SHE SHOULD HAVE RECEIVED A "RETRACTABLE" SYRINGE FOR HER B-12 SHOTS STATED, THE WRONG SYRINGES WILL LEAK WHEN ADMINISTERING HER SHOT AND ONCE, THE NEEDLE HUB SEPARATED WHEN REMOVING SHIELD.".

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11091404 ↗
• MalfunctionJul 6, 2020Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT THERE WAS NO EXPIRATION DATE ON THE SYRINGE SAFETYLOK 3ML LL W/NDL 25X5/8 BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "CONSUMER REPORTED NO EXP DATE ON BOX. FOUND WITHIN HER STORAGE WAS USING FOR BD. SHE WILL BE DISCARDING THESE SYRINGES."

  Patient problems: No Patient Involvement

  MAUDE report 10237795 ↗
• MalfunctionMay 13, 2019Mechanical Problem

  IT WAS REPORTED THAT BD SAFETY-LOK¿ SYRINGE W/ DETACHABLE NEEDLE SAFETY MECHANISM FAILED TO ENGAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 309592 BATCH NO: UNKNOWN. IT WAS REPORTED THAT SAFETY MECHANISM FAILED TO ENGAGE AND WAS PULLED OFF OF THE SYRINGE. I HAVE A BD NEEDLE REF # (B)(4) THE SAFETY MECHANISM FAILED TO ENGAGE AND WAS PULLED OFF THE SYRINGE. I DON'T HAVE THE ORIGINAL PACKAGING, SO I CANNOT PROVIDE A LOT NUMBER, BUT I DO HAVE THE NEEDLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8603777 ↗
• MalfunctionOct 23, 2018Contamination /Decontamination Problem

  IT WAS REPORTED WITH THE USE OF THE BD SAFETY-LOK SYRINGE WITH DETACHABLE NEEDLE THERE WAS AN ISSUE WITH FOREIGN MATTER. THERE WAS NO REPORT OF INJURY OR MEDICAL INTERVENTION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7995880 ↗
• MalfunctionMay 31, 2018Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT OUT OF 2 BOXES, 15 BD SAFETY-LOK¿ SYRINGES WITH DETACHABLE NEEDLES WERE FOUND WITH FOREIGN MATTER "APPEARS TO BE INK OR PAINT SPOTS" INSIDE AND OUTSIDE OF THE BARREL. THERE WAS NO REPORT OF EXPOSURE, SERIOUS INJURY, OR MEDICAL INTERVENTION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7559033 ↗
• MalfunctionMay 22, 2018Fail-Safe Design Failure; Defective Device

  IT WAS REPORTED THE SAFETY MECHANISM ON A BD SAFETY-LOK¿ SYRINGE WITH DETACHABLE NEEDLE FAILED AS IT "WAS NOT LOCKING IN PLACE". THERE WAS NO REPORT OF EXPOSURE, SERIOUS INJURY OR MEDICAL INTERVENTION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7532372 ↗
• MalfunctionMay 22, 2018Device Operates Differently Than Expected

  IT WAS REPORTED THE SAFETY MECHANISM ON A BD SAFETY-LOK¿ SYRINGE WITH DETACHABLE NEEDLE FAILED AS IT "WAS NOT LOCKING IN PLACE". THERE WAS NO REPORT OF EXPOSURE, SERIOUS INJURY OR MEDICAL INTERVENTION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7531733 ↗
• MalfunctionMay 18, 2018Device Operates Differently Than Expected

  IT WAS REPORTED THAT AFTER USE A BD SAFETY-LOK¿ SYRINGE MALFUNCTIONED AS THE SAFETY DEVICE FAILED."THE SHIELD WHICH SHOULD LOCK IN PLACE, PULLED OFF THE TOP OF THE NEEDLE AFTER THE INJECTION" THERE WAS NO REPORT OF EXPOSURE, INJURY OR MEDICAL INTERVENTION NEEDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7527724 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K944757. One submission often covers many models, so check the product and lot details in each record.

• Z-2008-2019 · Feb 1, 2019 · Terminated
  3mL Safety-Lok Syringe, Catalog Number 309606, UDI 30382903096061