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

Model Number 129414M

Device Problems Gas/Air Leak (2946); Material Deformation (2976)

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

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 patient had the latex foley catheter placed on (b)(6) 2019.The balloon only deflated about 0.5 ml at a time, and took about 5 minutes for the catheter to be removed from the patient.Once the catheter was out, they were able to replicate this on this foley.There was no issue with the catheter draining.Per additional information received from the complainant on 21oct2019, saline was inserted into the balloon after it was out of the patient in attempt to troubleshoot the issue with the balloon.Per sample evaluation on (b)(6) 2019, it was found that the balloon was asymmetrical.

Manufacturer Narrative

The reported event was unconfirmed.A temperature sensing foley with a molex connector was returned attached to a meter bag.A saline syringe was attached to its inflation funnel.The catheter was inflated with 10 ccs using a 10 cc leur lock syringe.The balloon was found to asymmetric.However it was within specifications, as the asymmetry was less than 70/30.Based on the event description, the device appeared to be used for treatment.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: ¿visually inspect the product for any imperfections or surface deterioration prior to use.¿ 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 patient had the latex foley catheter placed on (b)(6) 2019.The balloon only deflated about 0.5 ml at a time, and took about 5 minutes for the catheter to be removed from the patient.Once the catheter was out, they were able to replicate this on this foley.There was no issue with the catheter draining.Per additional information received from the complainant on 21oct2019, saline was inserted into the balloon after it was out of the patient in attempt to troubleshoot the issue with the balloon.Per sample evaluation on 22oct2019, it was found that the balloon was asymmetrical.

• Brand Name: BARDEX® I.C. TEMPERATURE SENSING FOLEY CATHETER
• Type of Device: TEMPERATURE SENSING FOLEY CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 9315944
• MDR Text Key: 179446773
• Report Number: 1018233-2019-07284
• Device Sequence Number: 1
• Product Code: MJC
• UDI-Device Identifier: 00801741046322
• UDI-Public: (01)00801741046322
• Combination Product (y/n): N
• PMA/PMN Number: K910318
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Type of Report: Initial,Followup
• Report Date: 11/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/13/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/12/2024
• Device Model Number: 129414M
• Device Catalogue Number: 129414M
• Device Lot Number: MCDQ1558
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/24/2019
• Date Manufacturer Received: 11/12/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1