MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 BARD CENTER ENTRY COUDE FOLEY TRAY WITH BARDEX LUBRICATH FOLEY CATHETER

Model Number	901116
Medical Device Problem Code	Deformation Due to Compressive Stress (2889)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/21/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.
Event or Problem Description
It was reported that customer had been having multiple issues with tubing being kinked in their foleys and disturbing urine flow.
Additional Manufacturer Narrative
The reported event was inconclusive.It was unknown whether the device had met specifications.The product was used for treatment purposes.It was unknown whether the product had caused the reported failure.No sample was returned for evaluation.A potential root cause for this failure could be due to "kinked tubing".The device was not returned for evaluation.The lot number is unknown; therefore, the device history record could not be reviewed.The instructions for use were found adequate and state the following: 1.Don¿t disconnect, pull on, or twist your catheter or the drainage bag tubing.2.If you notice leaks in the system, notify your nurse immediately.3.Keep the drainage bag below the level of your bladder at all times.Do not place the drainage bag on its side - always keep the bag in an upright position.4.Do not empty the drainage bag yourself.* notify your nurse if the bag becomes full.The device was not returned.
Event or Problem Description
It was reported that customer had been having multiple issues with tubing being kinked in their foley and disturbing urine flow.

• Brand Name: BARD CENTER ENTRY COUDE FOLEY TRAY WITH BARDEX LUBRICATH FOLEY CATHETER
• Common Device Name: FOLEY CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• MDR Report Key: 11999584
• Report Number: 1018233-2021-03514
• Device Sequence Number: 14349712
• Product Code: EZC
• UDI-Device Identifier: 00801741024122
• UDI-Public: (01)00801741024122
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K910846
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/12/2021

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
• Operator of Device: Health Professional
• Device Model Number: 901116
• Device Catalogue Number: 901116
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 05/21/2021
• Initial Date Received by Manufacturer: 05/21/2021
• Supplement Date Received by Manufacturer: 08/12/2021
• Initial Report FDA Received Date: 06/15/2021
• Supplement Report FDA Received Date: 09/06/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other