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

Model Number 119110

Device Problems Leak/Splash (1354); Material Puncture/Hole (1504); Device Fell (4014)

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

Event Date 07/16/2020

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 fell out.When the user inflated the catheter that had fallen out, the catheter leaked around the valve.Per additional information received on 29jul2020, water leaked from the catheter and seemed that there were no visible damage to the catheter.Catheter was replaced to the patient due to leak from the valve.

Manufacturer Narrative

The reported event was confirmed.Visual inspection noted one temperature sensing foley catheter was received.Visual evaluation noted no obvious defects were observed.Attempted to inflate the catheter's balloon with 3.5 ml methylene blue solution (3 drops 1% aq methylene blue per 100ml distilled water) and the solution immediately leaked from a pinhole measuring 0.012" just under the inflation cap.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 fixture slot to position cap out of the specification.The product was used for the treatment purposes.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 catheter fell out.When the user inflated the catheter that had fallen out, the catheter leaked around the valve.Per additional information received on (b)(6) 2020, water leaked from the catheter and seemed that there was no visible damage to the catheter.The catheter was replaced to the patient due to a leak from the valve.

• Brand Name: BARDEX ALL-SILICONE TEMPERATURE-SENSING PEDIATRIC 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: 10396803
• MDR Text Key: 203464445
• Report Number: 1018233-2020-05115
• Device Sequence Number: 1
• Product Code: EZL
• UDI-Device Identifier: 00801741046001
• UDI-Public: (01)00801741046001
• 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: 11/23/2020

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: 09/30/2023
• Device Model Number: 119110
• Device Catalogue Number: 119110
• Device Lot Number: NGCW0940
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/11/2020
• Initial Date Manufacturer Received: 07/21/2020
• Initial Date FDA Received: 08/12/2020
• Supplement Dates Manufacturer Received: 11/02/2020
• Supplement Dates FDA Received: 11/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1