MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 BARD LUBRICATH FOLEY CATHETER

Model Number 365714

Device Problem Difficult to Remove (1528)

Patient Problems No Patient Involvement (2645); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/24/2020

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 catheter balloon would not deflate.Per additional information received via email from the ibc on 30oct2020, the nurse reported that the balloon inflated prior to insertion and unable to deflate.The catheter was then set aside.It was noted that there was a long gap between the initial discovery and mailed the product out to the nurse.The nurse noticed that the balloon significantly deflated by itself by the time when the catheter was packaged up.The catheter handled minimally.

Manufacturer Narrative

The reported event was unconfirmed since the problem could not be reproduced.No root cause could be found because the reported event was unconfirmed.A potential root cause for this failure mode could be, ¿manufacturing related due to operator error/ mechanical error/ thin rubberized layer/collapse lumen.¿ 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: "to deflate catheter balloon: gently insert a syringe in the catheter valve.Never use more force than is required to make the syringe "stick" in the valve.If you notice slow or no deflation, re-seat the syringe gently.Use only gentle aspiration to encourage deflation if needed.Vigorous aspiration may collapse the inflation lumen, preventing balloon deflation.If permitted by hospital protocol, the valve arm may be severed.If this fails, contact and adequately trained professional for assistance, as directed by hospital protocol." 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.H3 other text : the actual/suspected device was inspected.

Event Description

It was reported that the catheter balloon would not deflate.Per additional information received via email from the ibc on 30oct2020, the nurse reported that the balloon inflated prior to insertion and unable to deflate.The catheter was then set aside.It was noted that there was a long gap between the initial discovery and mailed the product out to the nurse.The nurse noticed that the balloon significantly deflated by itself by the time when the catheter was packaged up.The catheter handled minimally.

• Brand Name: BARD LUBRICATH FOLEY CATHETER
• Type of Device: FOLEY CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• MDR Report Key: 10837397
• MDR Text Key: 216347486
• Report Number: 1018233-2020-20946
• Device Sequence Number: 1
• Product Code: EZC
• UDI-Device Identifier: 00801741077739
• UDI-Public: (01)00801741077739
• Combination Product (y/n): N
• PMA/PMN Number: K910846
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 04/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/28/2023
• Device Model Number: 365714
• Device Catalogue Number: 365714
• Device Lot Number: MYDP4480
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/02/2020
• Initial Date Manufacturer Received: 10/23/2020
• Initial Date FDA Received: 11/13/2020
• Supplement Dates Manufacturer Received: 04/13/2021
• Supplement Dates FDA Received: 05/06/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other