FDA Adverse Event Malfunction Summary report: N

X-FLOW CATHETER

MDR report key: 10145575 · Received June 11, 2020

Report

Report Number: 9610711-2020-00022
Event Type: Malfunction
Date Received: June 11, 2020
Date of Event: May 13, 2020
Report Date: July 16, 2020
Manufacturer: COLOPLAST A/S
Product Code: EZL
UDI-DI: 03600040144442
PMA / PMN Number: K013172
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: MY
Reporter Occupation: OTHER HEALTH CARE PROFESSIONAL

Narratives

Additional Manufacturer Narrative · 0

AFTER RECEIVING THIS COMPLAINT, WE SEARCHED FOR OTHER COMPLAINT AND WE DIDN'T FIND OTHER COMPLAINT ON THE LOT N°7105577. THE PRODUCT REFERENCE AB63221002 LOT NUMBER 7105577 WAS MADE WITH THE INTERMEDIATE PRODUCT AB632280 LOT NUMBER 6894474. NO SAMPLE IS AVAILABLE FROM THE CUSTOMER, BUT IN FILE ATTACHMENT, MOVIES SHOW A BURSTS BALLOON AND ENTIRE. THE BALLOON BURST ISSUE IS KNOWN. POSSIBLE ROOT CAUSE IS A WEAKNESS AREA IN THE SILICONE MATERIAL OF THE BALLOON. IN PARALLEL, A SPECIFIC TREND IS MONITORED REGARDING THE SILICONE BALLOON ISSSUE.

Additional Manufacturer Narrative · 1

WITHOUT THE BENEFIT OF EXAMINATION AND TESTING, COLOPLAST IS PRECLUDED FROM COMMENTING ON THE CONDITION OF THE DEVICE OR THE CAUSE OF THE OCCURRENCE. ONCE OUR EVALUATION IS COMPLETE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

Description of Event or Problem · 1

ACCORDING TO THE AVAILABLE INFORMATION, BALLOON WAS INFLATED TO 40ML WITH WATER. CATHETER SLIPPED OUT WHEN THE PATIENT WAS IN THE WARD. PATIENT WAS ON SPINAL ANESTHESIA AND WASN'T MOVING AROUND. NURSE AND THE DOCTOR INSPECTED ON THE PATIENT AND CATHETER, FOUND THAT THE BALLOON RUPTURED WITH A SPLIT. THE DOCTOR HAD TO DISCARD THE CATHETER YESTERDAY AS IT WAS CONTAMINATED WITH BLOOD. NEW DUFOUR CATHETER, SAME SIZE (22FR), WAS INSERTED AGAIN.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
605690	X-FLOW CATHETER	SILICONE CATHETER	EZL	COLOPLAST A/S	AB63221002	7105577	03600040144442

Patients

Seq	Age	Sex	Outcome	Treatment
1