inforMED
MalfunctionFMJ

HYPODERMIC NEEDLE-PRO WITH NEEDLE PROTECTION DEVICE

Received Jun 12, 2015 · Event occurred May 18, 2015

Report 2183502-2015-00409 · MDR key 4848275

Device

Generic name

Fmj - Needle, Hypodermic

Model number

NA

Catalog number

G1746

Lot number

UNK

Product problems

  • Detachment Of Device Component

Patient

UNK

  • No Consequences Or Impact To Patient

Narrative

Description of Event or Problem

A REPORT WAS RECEIVED EXPLAINING THAT DURING AN INJECTION, THE NEEDLE BECAME DETACHED FROM THE SYRINGE AND TEMPORARILY REMAINED IN THE PT. STERILE MEDICATION PROJECTED OUT OF THE SYRINGE AND ONTO NURSE'S HANDS, FACE AND CLOTHING. THE REPORTER INDICATED THAT NO ADDITIONAL INFO REGARDING MEDICATION EXPOSURE IS AVAILABLE. NO NEEDLE-STICK TOOK PLACE. NO PERMANENT ADVERSE EFFECTS TO CLINICIAN OR PT 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.