FDA Adverse Event Malfunction Summary report: N

EZ-IO 25MM NEEDLE SET + STABILIZER(BOX O

MDR report key: 9234840 · Received October 24, 2019

Report

Report Number: 3011137372-2019-00385
Event Type: Malfunction
Date Received: October 24, 2019
Date of Event: May 6, 2019
Report Date: May 7, 2019
Manufacturer: TELEFLEX MEDICAL
Product Code: FMI
PMA / PMN Number: K091140
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: OR, US
Reporter Occupation: RISK MANAGER

Narratives

Additional Manufacturer Narrative · 1

(B)(4). ONE (1) EZ-IO NEEDLE SET 9001P-VC-005 (LOT/BATCH 5988731) WAS RECEIVED WITH THE NEEDLE PACK COMPONENTS LOOSE IN A (B)(6) BAG FOR INVESTIGATION. UPON RECEIPT THE NEEDLE SET WAS VISUALLY INSPECTED. IT SHOULD BE NOTED THE NEEDLE SET IS NOT IN ITS ORIGINAL PACKAGING. THE NEEDLE SET PROTECTIVE SHEATH WAS DETACHED AND LOOSE IN THE (B)(6) BAG. THE COMPLAINT HAS BEEN CONFIRMED. THE DEVICE HISTORY FILE IS NOT AVAILABLE FOR REVIEW IN THE US. THE CERTIFICATE OF COMPLIANCE CERTIFIES THAT THE LOT MEETS THE LAKE REGION MEDICAL QUALITY SYSTEM REQUIREMENTS AND SPECIFICATIONS. THIS PRODUCT HAS BEEN MANUFACTURED AND CONTROLLED BY LAKE REGION MEDICAL IN ACCORDANCE WITH THE FDA QSR AND ISO 13485:2003. THE COMPLAINT HAS BEEN CONFIRMED VIA VISUAL INSPECTION. ATHLONE (LEGAL MANUFACTURER) HAS ISSUED A NON-CONFORMANCE TO ADDRESS THE DETACHED NEEDLE SHEATH (PROTECTIVE CAP) ISSUE. TELEFLEX WILL CONTINUE TO MONITOR AND TREND RELATED EVENTS. OTHER REMARKS:

Description of Event or Problem · 1

IT WAS REPORTED THAT THE CAP OR GUARD CAME OFF ONE OF THE NEEDLES. WHEN THE FIREMAN REACHED INTO THE CABINET TO RETRIEVE, HE GOT STUCK BY THE NEEDLE. THEY DID A CHECK AND FOUND ANOTHER ONE THAT THE CAP OR GUARD WAS OFF BUT THERE WAS NO HARM WITH THE SECOND ONE.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1027995	EZ-IO 25MM NEEDLE SET + STABILIZER(BOX O	NEEDLE, HYPODERMIC, SINGLE LU	FMI	TELEFLEX MEDICAL		5988731

Patients

Seq	Age	Sex	Outcome	Treatment
1