FDA Adverse Event Injury Summary report: N

MICRO PUNCTURE KIT

MDR report key: 19894137 · Received August 1, 2024

Report

Report Number
MW5157925
Event Type
Injury
Date Received
August 1, 2024
Date of Event
July 1, 2024
Report Date
July 29, 2024
Manufacturer
TELEFLEX LLC
Product Code
DYB
Product Problem
Yes
Report Source
Voluntary report
Reporter Location
IL, US
Reporter Occupation
NURSE
Health Professional
Yes

Narratives

Description of Event or Problem · 0

WIRE TIP BROKE OFF THE WIRE INSIDE THE PATIENT WHILE TWO WIRES WERE IN THE BODY FROM TWO DIFFERENT LEFT SUBCLAVIAN ACCESS SITES. WIRE TIP WAS RETRIEVED BY THE INTERVENTIONAL RADIOLOGY TEAM.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
383781 MICRO PUNCTURE KIT INTRODUCER, CATHETER DYB TELEFLEX LLC IPN916062 73C2400407

Patients

Seq Age Sex Outcome Treatment
1 78 YR Female Required Intervention