MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 BARDEX® I.C. COMPLETE CARE® TEMP-SENSING FOLEY CATHETER WITH URINE METER; DRAIN BAG

Model Number	319416AM
Health Effect - Clinical Code	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 drain bag would not drain urine.The complainant alleged that drain bag appeared to have a vapor lock and only drained upon manipulation.
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: "visually inspect the product for any imperfections or surface deterioration prior to use.If package is opened or damaged or if any imperfection or surface deterioration is observed, do not use.Maintain unobstructed urine flow and keep the catheter and collection tube free from kinking." (b)(4).
Event or Problem Description
It was reported that the drain bag would not drain urine.The complainant alleged that drain bag appeared to have a vapor lock and only drained upon manipulation.

• Brand Name: BARDEX® I.C. COMPLETE CARE® TEMP-SENSING FOLEY CATHETER WITH URINE METER
• Common Device Name: DRAIN BAG
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 6807318
• Report Number: 1018233-2017-04349
• Device Sequence Number: 10795490
• Product Code: MJC
• UDI-Device Identifier: 00801741024450
• UDI-Public: (01)00801741024450
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K040658
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/12/2017

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 Expiration Date: 10/31/2019
• Device Model Number: 319416AM
• Device Catalogue Number: 319416AM
• Device Lot Number: NGBP1485
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/31/2017
• Supplement Date Received by Manufacturer: 09/11/2017
• Initial Report FDA Received Date: 08/21/2017
• Supplement Report FDA Received Date: 09/12/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1