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

Catalog Number 129414M

Device Problems Device Damaged Prior to Use (2284); Material Deformation (2976); No Flow (2991)

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

Event Date 08/20/2018

Event Type  malfunction  

Manufacturer Narrative

The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.The information provided by bard 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 bard.

Event Description

It was reported that urine did not flow out allegedly due to the deformed catheter.

Manufacturer Narrative

The reported event was confirmed as cause unknown.The returned catheter was evaluated and observed to be deformed at the shaft near the funnel area.Per the functional evaluation, the product met the internal flow rate specification.Water was introduced through the drainage eye and came out from the drainage funnel without difficulty.The reported event was unable t be duplicated.How and when problem occurred 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: "21) since movement of the body, etc.May twist or bend catheter to cause occlusion, care should be taken to fix the catheter securely.22) when urinary flow cannot be noted, confirm that the catheter is neither occluded nor broken.".

Event Description

It was reported that urine did not flow out allegedly due to the deformed catheter.

• Brand Name: BARDEX® I.C. TEMPERATURE SENSING FOLEY CATHETER
• Type of Device: TEMPEATURE SENSING CATHETER (LATEX)
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 7864376
• MDR Text Key: 119944662
• Report Number: 1018233-2018-04101
• Device Sequence Number: 1
• Product Code: MJC
• 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: 11/09/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/11/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/01/2021
• Device Catalogue Number: 129414M
• Device Lot Number: 8AM7015
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/12/2018
• Date Manufacturer Received: 10/18/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1