McKesson 192-N231SRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10612479248554), received between Dec 17, 2020 and Dec 6, 2022 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Break” (1 report).

4 other recalls cover devices cleared under the same FDA submission (K951254); 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. How this data works · Data updated Oct 13, 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.

• MalfunctionDec 6, 2022Complete Blockage; Complete Blockage

  IT WAS REPORTED THAT THE BD SAFETYGLIDE NEEDLE WAS CLOGGED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: DURING ADMINISTRATION OF VACCINE RECEIVED RESISTANCE FROM NEEDLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15924305 ↗
• MalfunctionDec 29, 2020Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE NEEDLE SFTYGLD 23X1 RB MCK EXPERIENCED A NEEDLE THAT WAS LOOSE/PULLED OUT OF HUB. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 306610, BATCH NO: 0141219. DURING A ROUTINE FLU VACCINATION ADMINISTRATION, A SAFETY NEEDLE WAS USED. ADMINISTRATION COMPLETED WITHOUT AN ISSUE, HOWEVER, ONCE THE NEEDLE WAS ATTEMPTED TO BE RETRACTED FROM THE PATIENTS SKIN, THE PROVIDER REPORTED THE FOLLOWING: "[I] WAS ABLE TO GIVE THE VACCINE BUT WHEN PULLING OUT THE NEEDLE, IT REMAINED IN THE PATIENTS SKIN STICKING FROM THE RIGHT THIGH. I WAS ABLE TO PULL THE NEEDLE OUT WITH MY HAND WITH NO INJURY OR HARM TO THE PATIENT". WE HAD A SAFETY NEEDLE SEPARATE FROM THE ASSEMBLY AND REMAIN IN THE PATIENT DURING A ROUTINE FLU VACCINATION ADMINISTRATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11091469 ↗
• MalfunctionDec 17, 2020Break; Material Protrusion/Extrusion; Break; Material Protrusion/Extrusion

  IT WAS REPORTED THAT A NEEDLE SFTYGLD 23X1 RB MCK HAD THE SAFETY MECHANISM FAIL AND THE CANNULA BREAK DURING USE. THE FOLLOWING WAS REPORTED BY THE INITIAL REPORTER: "IT WAS REPORTED THAT THE NEEDLE BROKE AFTER THE SAFETY MECHANISM WAS ENGAGED EVENT DESCRIPTION PER ATTACHED EMAIL STATES: NEEDLE BROKE OFF ONCE SAFETY MECHANISM WAS ENGAGED THE NEW PREVENT SG NEEDLE BROKE OFF FROM SYRINGE ONCE THE SAFETY MECHANISM WAS ENGAGED. CUSTOMER HAS A FULL BOX AND SOME OF ANOTHER BOX.".

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11032785 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K951254. One submission often covers many models, so check the product and lot details in each record.

• Z-2889-2020 · Jul 28, 2020 · Terminated
  BD SafetyGlideTM 3ml 25G x 1 3mL SafetyGlide syringes, 50 units in pack
• Z-0315-2018 · Jul 5, 2017 · Terminated
  SafetyGlide Needle, 22GA 1-1/2in, Catalog n. 301701, manufactured by BD, sold in Centurion Convenience Kits. Centurion component code BD17O1NS.
• Z-3116-2017 · Jun 13, 2017 · Terminated
  BD Needle 22GA 1-1/2in SafetyGlide(TM) Non Sterile, Bulk, REF 301701 The BD SafetyGlide(TM) needle is intended to be used for general purpose injection, aspiration of fluids from
• Z-2748-2017 · Sep 16, 2016 · Terminated
  BD SafetyGlide" Injection Needle Catalog #305917 The SafetyGlide " needle is intended to be used for general purpose injection, aspiration of fluids from parts of the body below th