MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 BARDIA FOLEY CATHETER SILICONE COATED; BARDIA 2 WAY FOLEY CATHETER

Model Number 123516A

Device Problems Deflation Problem (1149); Difficult to Remove (1528)

Patient Problems No Patient Involvement (2645); No Known Impact Or Consequence To Patient (2692)

Event Date 04/20/2020

Event Type  malfunction  

Manufacturer Narrative

The investigation is still in progress.Once the investigation is complete, a supplemental report will be filed.The device was not returned.

Event Description

It was reported that the catheter balloon was difficult to deflate during a pretest.

Event Description

It was reported that the catheter balloon was difficult to deflate during a pretest.

Manufacturer Narrative

The reported event was inconclusive as no sample was returned for evaluation.However, the potential root cause for this failure mode could be due to user related (example: over aspirated, incorrect syringe)/ collapse lumen/ sac close eye/ valve damage.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 served.If this fails, contact an 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 device was not returned.

• Brand Name: BARDIA FOLEY CATHETER SILICONE COATED
• Type of Device: BARDIA 2 WAY FOLEY CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 10047825
• MDR Text Key: 191103801
• Report Number: 1018233-2020-03146
• Device Sequence Number: 1
• Product Code: EZC
• UDI-Device Identifier: 00801741095092
• UDI-Public: (01)00801741095092
• 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,other
• Type of Report: Initial,Followup
• Report Date: 07/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/12/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 04/28/2024
• Device Model Number: 123516A
• Device Catalogue Number: 123516A
• Device Lot Number: MYDT0382
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/26/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1