FDA Adverse Event Malfunction Summary report: N

IV3000 1 HAND 10X12CM CTN 50

MDR report key: 8765900 · Received July 6, 2019

Report

Report Number: 8043484-2019-00461
Event Type: Malfunction
Date Received: July 6, 2019
Date of Event: June 17, 2019
Report Date: August 28, 2019
Manufacturer: SMITH & NEPHEW MEDICAL LTD.
Product Code: KGX
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: CH
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 0

OUR INVESTIGATION INTO THE COMPLAINT HAS NOW CONCLUDED. A DEVICE HISTORY RECORD REVIEW WAS CARRIED OUT FOR THE LOT SUPPLIED. THIS CONFIRMED THAT THE PRODUCT HAD BEEN MANUFACTURED IN ACCORDANCE WITH DEFINED PROCEDURES AND SPECIFICATIONS. THERE WAS NO RECORD OF ANY PROBLEMS OR DEVIATIONS OCCURRING DURING THE MANUFACTURING OF THIS PRODUCT IN RELATION TO THE REPORTED ISSUE. VISUAL INSPECTION AND FUNCTIONAL EVALUATION OF THE SAMPLES RETURNED FOR COMPLAINT (B)(4) DID NOT IDENTIFY ANY ISSUES. ON THIS OCCASION WE ARE UNFORTUNATELY UNABLE TO REACH A DEFINITIVE ROOT CAUSE OF THE PROBLEM, HOWEVER SMITH AND NEPHEW ARE CONTINUALLY INVESTIGATING WAYS TO DEVELOP AND IMPROVE OUR PRODUCTS AND WE WILL CONTINUE TO MONITOR FOR ANY ADVERSE TRENDS RELATING TO THIS PRODUCT RANGE.

Description of Event or Problem · 1

IT WAS REPORTED THAT THE FILM HAS LOW ADHESION, THERE WAS NO PATIENT HARM.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
559420	IV3000 1 HAND 10X12CM CTN 50	TAPE AND BANDAGE, ADHESIVE	KGX	SMITH & NEPHEW MEDICAL LTD.		1804

Patients

Seq	Age	Sex	Outcome	Treatment
1