MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 BARDEX® I.C. FOLEY CATHETER; FOLEY CATHETER (LATEX)

Model Number 0165SI14

Device Problems Deflation Problem (1149); Use of Device Problem (1670)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 12/25/2019

Event Type  malfunction  

Manufacturer Narrative

The investigation is still in progress.Once the investigation is complete, a supplemental report will be filed.

Event Description

It was reported that the user was unable to inject water into a balloon after placement.The user discontinued to use the device and placed another device.

Manufacturer Narrative

The reported issue was confirmed.The device was returned for evaluation.Visual inspection found a tear on the sac collar (top) of the catheter and observed there was a dented mark at the tear area.Unable to determine the origin of defect.How and where problem occurred could not be determined.Potential root cause for this failure mode could be user related (example: contact with sharp object)/mechanical failure/operator error/thin rubberize layer).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: ¿[warnings] 1.Method for use (1) do not inflate the balloon in the urethra.[the urethra may be injured.] (2) do not pull the catheter hard.[the bladder/urethra may be injured.] [directions for use] (6) insert catheter into the urethral meatus, and advance it until the balloon enters the bladder and urine flows out through the catheter.Using a syringe packaged in the tray, infuse the specified volume of sterile water into the inflation lumen to inflate the balloon." h11:section a through f - the information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.

Event Description

It was reported that the user was unable to inject water into a balloon after placement.The user discontinued to use the device and placed another device.

• Brand Name: BARDEX® I.C. FOLEY CATHETER
• Type of Device: FOLEY CATHETER (LATEX)
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 9633608
• MDR Text Key: 181375031
• Report Number: 1018233-2020-00544
• Device Sequence Number: 1
• Product Code: MJC
• UDI-Device Identifier: 00801741016745
• UDI-Public: (01)00801741016745
• Combination Product (y/n): N
• PMA/PMN Number: K910318
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,other
• Type of Report: Initial,Followup
• Report Date: 03/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/27/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/28/2022
• Device Model Number: 0165SI14
• Device Catalogue Number: 0165SI14
• Device Lot Number: 9GU027
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/15/2020
• Date Manufacturer Received: 03/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1