FDA Adverse Event Malfunction Summary report: N

DELTEC GRIPPER PLUS POWER PAC

MDR report key: 9621397 · Received January 23, 2020

Report

Report Number
9621397
Event Type
Malfunction
Date Received
January 23, 2020
Date of Event
October 24, 2019
Report Date
October 31, 2019
Manufacturer
SMITHS MEDICAL ASD, INC
Product Code
FPA
Product Problem
Yes
Report Source
User Facility report
Reporter Location
TN
Reporter Occupation
RISK MANAGER

Narratives

Description of Event or Problem · 1

NURSE WAS ACCESSING THE PATIENT'S PORT-A-CATH, WHICH HAD BEEN ACCESSED BY THE SAME NURSE SEVERAL DAYS EARLIER WITHOUT INCIDENT. DURING ATTEMPT TO ACCESS, THE PATIENT GRIMACED AND MADE A HISSING NOISE. IT WOULD NOT FLUSH OR DRAW, SO THE NEEDLE WAS WITHDRAWN A SMALL DISTANCE. IT FLUSHED, BUT STILL WOULD NOT DRAW. THE PORT WAS DE-ACCESSED. THE NURSE RAN HER FINGER ALONG THE EDGE OF THE NEEDLE AND IT WAS ROUGH INSTEAD OF SMOOTH. NURSE STATES IT FELT LIKE THERE WAS A BURR ON THE EDGE THAT WAS ON THE REVERSE OF THE BEVELED SIDE. A NEW NEEDLE WAS OBTAINED AND THE PORT WAS ACCESSED WITHOUT INCIDENT. THERE WAS NO KNOWN HARM TO THE PATIENT. THERE ARE TWO LOT # PROVIDED BECAUSE NURSE IS NOT SURE FROM WHICH ONE THE NEEDLE WAS PULLED. 2ND LOT # 3854215, EXPIRATION DATE: 08/16/2024.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
86753 DELTEC GRIPPER PLUS POWER PAC SET, ADMINISTRATION, INTRAVASCULAR FPA SMITHS MEDICAL ASD, INC 3865519

Patients

Seq Age Sex Outcome Treatment
1 20075 DA