inforMED
MalfunctionFMJ

HYPODERMIC NEEDLE-PRO NEEDLE WITH PROTECTION DEVICE

Received Jun 8, 2015

Report 2183502-2015-00404 · MDR key 4838147

Device

Generic name

Hypodermic Needle

Model number

NA

Catalog number

4658305

Lot number

2736438

Product problems

  • Detachment Of Device Component

Patient

UNK

  • No Consequences Or Impact To Patient

Narrative

Additional Manufacturer Narrative

MANUFACTURER COMPLETED THE ENTIRE FORM. 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.

Description of Event or Problem

A REPORT WAS REC'D THAT STATE DURING AN INJECTION, THE NEEDLE BECAME DETACHED FROM THE SYRINGE. NO NEEDLE-STICK TOOK PLACE. THERE WAS NO PT OR CLINICIAN INJURY REPORTED.