MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 BARD® URINARY DRAINAGE TUBE; DRAIN TUBING

Catalog Number	017514
Medical Device Problem Code	Restricted Flow rate (1248)
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 information provided by bard 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 bard.The device was not returned.
Event or Problem Description
It was reported that the urine was backing up in the drain tubing.
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 state the following: "sterile unless package is opened or damaged.3/16 in.Lumen 60 in.Length single use only.Do not resterilize.Caution: federal (u.S.A.) law restricts this device to sale by or on the order of a physician.Bard is a registered trademark of c.R.Bard, inc.".
Event or Problem Description
It was reported that the urine was backing up in the drain tubing.

• Brand Name: BARD® URINARY DRAINAGE TUBE
• Common Device Name: DRAIN TUBING
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 7496523
• Report Number: 1018233-2018-01565
• Device Sequence Number: 16693304
• Product Code: KNX
• UDI-Device Identifier: 00801741052545
• UDI-Public: (01)00801741052545
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer,distributor,other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/18/2018

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: 10/31/2021
• Device Catalogue Number: 017514
• Device Lot Number: NGAX4087
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/17/2018
• Supplement Date Received by Manufacturer: 05/15/2018
• Initial Report FDA Received Date: 05/08/2018
• Supplement Report FDA Received Date: 05/18/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 72 YR