BD SafetyGlide 305946Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00382903059461), received between Jan 28, 2019 and Jul 26, 2019 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (3 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 26, 2019Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT A DIFFICULT PLUNGER OCCURRED DURING USE WITH A SYRINGE SFTYGLD 1ML W/NDL 26X3/8 IB. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, "MED PULLED UP FINE INTO THE SYRINGE, BUT CAN¿T BE ADMINISTERED; PLUNGER WON¿T BUDGE. WE TESTED TOTAL OF 50 SYRINGES FROM THE 3 LOTS WE HAVE AND ALL WERE FINE. 2 OCCURRENCES WERE REPORTED DATE/TIME AND PATIENT INFORMATION WERE NOT GIVEN. 1 OF 2 COMPLAINTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8833855 ↗
• MalfunctionJul 10, 2019Leak/Splash; Leak/Splash

  MATERIAL NO. 305946 BATCH NO. UNKNOWN. IT WAS REPORTED THAT DURING USE OF THE SYRINGE SFTYGLD 1ML W/NDL 26X3/8 IB THE SYRINGE PLUNGER WOULD NOT DEPRESS. MEDICATION CAN BE PULLED UP, BUT CAN¿T BE ADMINISTERED. THE PLUNGER WILL NOT MOVE. THIS OCCURRED ON 2 SEPARATE OCCASIONS BUT THE DATE/TIME AND OR PATIENT INFORMATION IS UNKNOWN. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MED PULLED UP FINE INTO THE SYRINGE, BUT CAN¿T BE ADMINISTERED; PLUNGER WON¿T BUDGE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8778522 ↗
• MalfunctionApr 16, 2019Failure to Align

  IT WAS REPORTED THAT SYRINGE SFTYGLD 1ML W/NDL 26X3/8 IB HAD A SAFETY FAILURE. NO SERIOUS INJURY OR MEDICAL INTERVENTION WAS REPORTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO.: 305946 BATCH NO.: 8087774. IT WAS REPORTED THAT THE BEVEL DOES NOT LINE UP WITH THE SAFETY MECHANISM AND IT IS NOT ITS USUAL COLOR. THE BEVEL DOES NOT LINE UP WITH THE SAFETY. IN THE PAST, THE BEVEL ALWAYS LINED UP WITH THE SAFETY SO YOU KNOW WHERE THE BEVEL IS TO INSERT THE INTRADERMAL INJECTION. WHEN IT IS NOT LINED UP, IT MAKES IT EXTREMELY DIFFICULT TO FIND THE BEVEL AND INSERT. 305946 - WHY DOESN'T THE BEVEL LINE UP WITH THE SAFETY? AND AREN'T THEY USUALLY ORANGE?

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8518434 ↗
• MalfunctionJan 28, 2019Leak/Splash

  IT WAS REPORTED THAT BD¿ SYRINGE SFTYGLD 1ML W/NDL 26X3/8 IB LEAKED DURING INJECTION. NO SERIOUS INJURY OR MEDICAL INTERVENTION WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8280524 ↗