BD Safety-Lok 305559Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 30382903055594), received between Mar 13, 2019 and Aug 20, 2020 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 20, 2020Break; Leak/Splash; Break; Leak/Splash

  IT WAS REPORTED THAT SHARPS COLL WALLMATE 5.4 QT BEIGE WAS DAMAGED, BUT STILL OPERABLE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "IT WAS REPORTED THAT THE STRINGE WAS DAMAGED. EVENT DESCRIPTION PER ATTACHED EMAIL STATES: 35241, 19039, SYR 10 ML L/L NO REPL, 305559, N/A, DAMAGED, 1. WE WERE NOTIFIED ABOUT SOME COMPLAINTS FROM A CUSTOMER STATING THE FOLLOWING COMPONENTS ARE NOT MEETING THE SPECS. PHOTOS WERE RECEIVED AS A SAMPLE AND THE REPORTED ISSUES HAVE BEEN CONFIRMED. WE WANT TO ENSURE THAT YOU ARE AWARE OF THE ISSUES AND THAT WE DO REQUIRE A CAPA THAT ADDRESSES THE PARTICULATE ISSUE. ADDITIONALLY, INVESTIGATION IS REQUIRED FOR THE REMAINING CRITICAL DEFECT MODES (MISSING COMPONENT, DIRTY, DAMAGED AND HAIR).

  Patient problems: No Patient Involvement

  MAUDE report 10430392 ↗
• MalfunctionDec 9, 2019Device Markings/Labelling Problem; Device Markings/Labelling Problem

  MATERIAL NO: 305559, BATCH NO: 4294859. IT WAS REPORTED THAT BEFORE USE OF THE SYRINGE SAFETYLOK 10ML LL THE EXPIRATION DATE IS LISTED ON THE SHELF PACK BUT NOT ON THE INDIVIDUAL PRODUCT BLISTER PACKS. THE SHELF PACK HAS THE EXPIRATION DATE OF THE SYRINGES LISTED, BUT THERE IS NO EXPIRATION DATE ON THE INDIVIDUAL PACKAGES. THIS CAN LEAD TO USE OF EXPIRED PRODUCT ONCE THE SYRINGES ARE REMOVED FROM THE SHELF PACK.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9437671 ↗
• MalfunctionMar 13, 2019Leak/Splash

  IT WAS REPORTED THAT A SYRINGE SAFETYLOK 10ML LL HAD LEAKED. THE REPORT IS AS FOLLOWS, "PROBLEM: EXPERIENCING LEAKING WHILE USING THESE SYRINGES."

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8418604 ↗

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