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

Model Number 129416M

Device Problem Partial Blockage (1065)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/21/2021

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 a blue port was found in the bed that had cracked off of the foley tube where urine samples were obtained.Then a new foley catheter was placed however no urine output was observed.No resistance was met when inserting.Foley was irrigated but met resistance when flushing and red seal ripped open and disconnected the tubing from the catheter.Foley was removed and new one was placed.Old one was troubleshooted.When flushing, no fluid would flow through tip of foley as if it was occluded somewhere which is why it built up enough pressure for the red seal to break and per follow up response received via mail on 01mar2021, the whole port broke from the tubing.Also, patient was being tested covid positive.

Manufacturer Narrative

The reported event was inconclusive as no sample returned for evaluation.A potential root cause for this failure mode could be due to encrustation of eye from the biological material deposits.It was unknown whether the device had met relevant specifications.The product was used for treatment purposes.It was unknown whether the product had caused the reported failure.The device was not returned for evaluation.The lot number was unknown therefore the device history record could not be reviewed.The instructions for use were found adequate and state the following "proper techniques for urinary catheter insertion ¿ perform hand hygiene immediately before and after insertion ¿ insert urinary catheters using aseptic technique and sterile equipment ¿ use the smallest foley catheter possible, consistent with good drainage ¿ document the indications for catheter insertion, date and time of catheter insertion, individual who inserted catheter, and date and time of catheter removal in patient record proper techniques for urinary catheter maintenance ¿ secure the foley catheter, use the statlock foley stabilization device if provided ¿ maintain a closed drainage system by utilizing pre-connected, sealed catheter-tubing junctions ¿ maintain unobstructed urine flow and keep the catheter and collection tube free from kinking ¿ keep the collection bag below the level of the bladder or hips at all times ¿ empty the collection bag regularly (e.G., prior to transport) using a separate, clean collection container for each patient ¿ routine hygiene (e.G., cleansing of the metal surface during daily bathing or showering) is appropriate ¿ leave foley catheter in place only as long as needed" the device was not returned.

Event Description

It was reported that the blue port found in the bed was cracked off of the foley tube where the urine samples were obtained.Then a new foley catheter was placed however no urine output was observed and no resistance was met during insertion.The foley was irrigated but met resistance when flushing and red seal ripped open and disconnected the tubing from the catheter.The foley was removed and a new one was placed and the old one underwent troubleshooting.When flushing no fluid would flow through the tip of the foley as if it was occluded somewhere which was built up enough pressure for the red seal to break.Per follow up response received via email on 01mar2021 the whole port was broken from the tubing.Also the patient was being tested as covid positive.

• 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 30014
• MDR Report Key: 11520867
• MDR Text Key: 242943472
• Report Number: 1018233-2021-01440
• Device Sequence Number: 1
• Product Code: MJC
• UDI-Device Identifier: 00801741039775
• UDI-Public: (01)00801741039775
• Combination Product (y/n): N
• PMA/PMN Number: K040658
• Number of Events Reported: 1
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Source Type: other,user facility
• Type of Report: Initial,Followup
• Report Date: 06/23/2021

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 Model Number: 129416M
• Device Catalogue Number: 129416M
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/22/2021
• Initial Date FDA Received: 03/18/2021
• Supplement Dates Manufacturer Received: 06/23/2021
• Supplement Dates FDA Received: 07/18/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other