inforMED
MalfunctionFMJ

HYPODERMIC NEEDLE-PRO NEELDE WITH PROTECTION DEVICE

Received Jun 15, 2015

Report 2183502-2015-00417 · MDR key 4853595

Device

Generic name

Fmj - Hypodetrmic Needle

Model number

NA

Catalog number

4858305

Lot number

2551101

Product problems

  • Detachment Of Device Component

Patient

UNK

  • No Consequences Or Impact To Patient

Narrative

Description of Event or Problem

A REPORT WAS RECEIVED THAT STATED DURING AN INJECTION, THE NEEDLE BECAME DETACHED FROM THE SYRINGE. NO NEEDLE-STICK TOOK PLACE. THERE WAS NO PATIENT OR CLINICIAN INJURY REPORTED.

Additional Manufacturer Narrative

CUSTOMER HAS NOT YET RETURNED THE DEVICE TO THE MANUFACTURER FOR DEVICE EVALUATION. WHEN AND IF THE DEVICE BECOMES AVAILABLE AND IS RETURNED AND EVALUATED THE MANUFACTURER WILL FILE A FOLLOW-UP REPORT DETAILING THE RESULTS OF THE EVALUATION.