MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 BARD® CENTER ENTRY COUDE FOLEY TRAY; DRAIN BAG TUBING

Model Number	901116
Medical Device Problem Code	Deformation Due to Compressive Stress (2889)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
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.The device was not returned.
Event or Problem Description
It was reported that there was a kink in the tubing of the drain bag which allegedly caused the urine to drain slowly.
Event or Problem Description
It was reported that there was a kink in the tubing of the drain bag which allegedly caused the urine to drain slowly.
Additional Manufacturer Narrative
The device was not returned for evaluation.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: ¿.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.*procedures may be different for home health patients." 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.H3 other text : the device was not returned.

• Brand Name: BARD® CENTER ENTRY COUDE FOLEY TRAY
• Common Device Name: DRAIN BAG TUBING
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 9254847
• Report Number: 1018233-2019-06923
• Device Sequence Number: 18942139
• Product Code: EZC
• UDI-Device Identifier: 00801741024122
• UDI-Public: (01)00801741024122
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K910846
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/06/2019

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: Lay User/Patient
• Device Expiration Date: 07/31/2021
• Device Model Number: 901116
• Device Catalogue Number: 901116
• Device Lot Number: NGCY1688
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/08/2019
• Supplement Date Received by Manufacturer: 10/30/2019
• Initial Report FDA Received Date: 10/30/2019
• Supplement Report FDA Received Date: 11/06/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1