FDA Adverse Event Malfunction Summary report: N

BARDEX® LUBRICATH® FOLEY CATHETER

MDR report key: 8744140 · Received June 28, 2019

Report

Report Number: 1018233-2019-03437
Event Type: Malfunction
Date Received: June 28, 2019
Date of Event: June 3, 2019
Report Date: June 28, 2019
Manufacturer: C.R. BARD, INC. (COVINGTON) -1018233
Product Code: EZC
PMA / PMN Number: K910846
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: JA
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

THE REPORTED ISSUE WAS CONFIRMED. VISUAL INSPECTION NOTED IRREGULAR BALLOON BURST. NO PIECES OF SAC WERE MISSING. EVALUATION FOUND BALLOON SAC BURST. SAMPLE WAS EVALUATED UNDER MICROSCOPE AND NO CONDITIONS FOUND THAT COULD BE ASSOCIATED WITH THE REPORTED EVENT. EXACT CAUSE COULD NOT BE DETERMINED. THE DEVICE HISTORY RECORD WAS REVIEWED AND FOUND NOTHING THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. THE INSTRUCTIONS FOR USE WERE FOUND ADEQUATE AND STATE THE FOLLOWING: CONTRAINDICATIONS: METHOD FOR USE: BE CAREFUL THAT THE CATHETER IS NOT EXPOSED TO OINTMENTS, CONTRAST MEDIUM OR OIL-BASED LUBRICANTS (INCLUDING VEGETABLE OILS SUCH AS OLIVE OIL, MINERAL OILS SUCH AS WHITE PETROLATUM AND ANIMAL OILS) [THEY MAY DAMAGE THE DEVICE AND MAY BURST BALLOON]. DO NOT HOLD THE DEVICE WITH FORCEPS, ETC. AVOID CONTACT WITH ANY BLADES OR SHARP-EDGED INSTRUMENTS [CATHETER DAMAGE MAY CAUSE BALLOON RUPTURE AND ACCIDENTAL BALLOON REMOVAL OR FAILURE TO DEFLATE OR REMOVE THE BALLOON].

Description of Event or Problem · 1

IT WAS REPORTED THAT THE BALLOON BURST.PER EMAIL RECEIVED FROM (B)(6) REPRESENTATIVE ON 6-JUN-2019, THERE WERE NO PIECES MISSING FROM THE BALLOON OF THE CATHETER.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
536865	BARDEX® LUBRICATH® FOLEY CATHETER	FOLEY CATHETER (LATEX)	EZC	C.R. BARD, INC. (COVINGTON) -1018233		UNK

Patients

Seq	Age	Sex	Outcome	Treatment
1