MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 BARDEX LUBRI-SIL I.C. TEMPERATURE-SENSING ALL-SILICONE FOLEY CATHETER; TEMPERATURE SENSING CATHETER (SILICONE)

Model Number 119314

Device Problems Device Damaged Prior to Use (2284); Scratched Material (3020)

Patient Problem No Patient Involvement (2645)

Event Date 07/13/2020

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 scratch was found on the shaft when the package was opened.

Manufacturer Narrative

The reported event was confirmed.Visual inspection noted that one silicone temperature sensing catheter was received.Visual evaluation noted that there was a rough spot about half way down the shaft of the catheter that appears to be some sort of heat or abrasion damage.Although the reported event was confirmed, a root cause could not be determined.A potential root cause for this failure mode could be due to scale out of the specifications.The product was not used for the diagnosis or treatment.The product had failed to meet the specifications, and was influenced by the reported failure.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.The labelling review was not performed due to the labeling could not have prevented the reported failure.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 scratch was found on the shaft when the package was opened.

• Brand Name: BARDEX LUBRI-SIL I.C. TEMPERATURE-SENSING ALL-SILICONE FOLEY CATHETER
• Type of Device: TEMPERATURE SENSING CATHETER (SILICONE)
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 10378584
• MDR Text Key: 203105821
• Report Number: 1018233-2020-05021
• Device Sequence Number: 1
• Product Code: MJC
• UDI-Device Identifier: 00801741039843
• UDI-Public: (01)00801741039843
• Combination Product (y/n): N
• PMA/PMN Number: K070582
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,other
• Type of Report: Initial,Followup
• Report Date: 11/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/07/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 119314
• Device Catalogue Number: 119314
• Device Lot Number: NGDZ3712
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/07/2020
• Date Manufacturer Received: 10/18/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1