MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 18" EXTENSION TUBING WITH CONNECTOR, NON-STERILE

Catalog Number	150615
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 staying in the extension tubing.
Additional Manufacturer Narrative
The reported event was unconfirmed.The visual evaluation of the sample noted no obvious defects.The bag was filled with a methylene blue and water solution and the leg bag was able to intake through the inlet tubing and retain it in the bag as intended.The flip-flo valve of the bag was then flipped to allow the removal of the liquid from the bag, and the bag drained liquids as intended.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: "pull to open bard®.Latex-free extension tubing.For use with male external catheters.Recommended for use with all bard® male external catheters.Directions for use: 1.Insert universal adapter connecting cone into end of male external catheter.2.Measure distance to urine bag, and cut tubing if necessary.3.Attach tubing end to inlet cone of urine bag.(detach by rolling back tubing end from inlet cone)." corrections: lot#, concomitant medical products, device evaluated by mfr.
Event or Problem Description
It was reported that the urine was staying in the extension tubing.

• Brand Name: 18" EXTENSION TUBING WITH CONNECTOR, NON-STERILE
• Common Device Name: EXTENSION TUBING
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 7906028
• Report Number: 1018233-2018-04384
• Device Sequence Number: 13969046
• Product Code: NNW
• UDI-Device Identifier: 00801741050824
• UDI-Public: (01)00801741050824
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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,other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/04/2019

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 Catalogue Number: 150615
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/11/2018
• Initial Date Received by Manufacturer: 09/07/2018
• Supplement Date Received by Manufacturer: 01/02/2019
• Initial Report FDA Received Date: 09/25/2018
• Supplement Report FDA Received Date: 01/04/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1