FDA Adverse Event Injury Summary report: N

MAJOR UROLOGY KIT

MDR report key: 3836236 · Received May 21, 2014

Report

Report Number: 1423395-2014-00010
Event Type: Injury
Date Received: May 21, 2014
Report Date: May 16, 2014
Manufacturer: MEDLINE INDUSTRIES, INC.
Product Code: NWR
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: WA, US
Reporter Occupation: OTHER HEALTH CARE PROFESSIONAL

Narratives

Additional Manufacturer Narrative · 1

THE SURGERY TECH AT THE FACILITY REPORTED THAT DURING THE PREVIOUS 45 DAYS, THEY EXPERIENCED 6 INCIDENTS OF FOLEY CATHETER BALLOON RUPTURES APPROXIMATELY 3-5 DAYS POST OPERATIVELY. HE DID NOT HAVE DATES OF THE INCIDENTS BUT INDICATED ALL WERE MALE PTS WHO WERE STATUS POST PROSTATECTOMY AND RECONSTRUCTIVE SURGICAL PROCEDURES. HE ACKNOWLEDGED THE FOLEY CATHETER BALLOONS WERE INFLATED WITH 15ML OF FLUID DESPITE THE STATED BALLOON CAPACITY OF 10ML. NO SAMPLES WERE RETAINED FOR EVALUATION AND THE LOT NUMBERS OF THE CATHETERS ARE NOT KNOWN. THE CATHETERS WERE NOT REPLACED FOLLOWING THE BALLOON RAPTURE. HE COULD NOT CONFIRM ANY INJURY OR NEGATIVE CONSEQUENCE THAT RESULTED FROM THE INCIDENT BUT STATED THAT THREE PATIENTS RETURNED FOR SUBSEQUENT PROCEDURES. IT IS NOT CONFIRMED IF THE ABSENCE OF A CATHETER CAUSED OR CONTRIBUTED TO THE POST OP COMPLICATIONS. A ROOT CAUSE HAS NOT BEEN DETERMINED BUT DUE TO THE FACILITY'S PRACTICE OF INFLATING THE BALLOONS TO 15ML, RECOMMENDATIONS HAVE BEEN MADE FOR THEM TO CONSIDER UTILIZING FOLEY CATHETERS WITH LARGER BALLOON CAPACITIES.

Description of Event or Problem · 1

THE FOLEY CATHETER BALLOONS RUPTURED AFTER A FEW DAYS.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
301790	MAJOR UROLOGY KIT		NWR	MEDLINE INDUSTRIES, INC.		12IB9559

Patients

Seq	Age	Sex	Outcome	Treatment
1	UNK		Other