MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 LEG BAG WITH FLIP-FLO VALVE, FABRIC LEG STRAPS, 19 OZ., STERILE

Catalog Number	150719
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.
Event or Problem Description
It was reported that there was foreign material in the outlet valve of the leg bag that prevented urine from being drained out of the bag.
Additional Manufacturer Narrative
The reported event was confirmed as cause unknown.Received a piece of antimicrobial tube only for evaluation.During visual inspection it was confirmed that the piece received corresponded to antimicrobial tube and it contained a antimicrobial solution.The product catalog number 150719 does not contain an antimicrobial tube, per specification.The root cause of the piece of antimicrobial tube on the product could not be determined at this time.The lot number is unknown; therefore, the device history record could not be reviewed.The instructions for use states the following: "¿ sterile unless package is opened or damaged.¿ for single patient use.¿ read directions before use." (b)(4).
Event or Problem Description
It was reported that there was foreign material in the outlet valve of the leg bag that prevented urine from being drained out of the bag.

• Brand Name: LEG BAG WITH FLIP-FLO VALVE, FABRIC LEG STRAPS, 19 OZ., STERILE
• Common Device Name: LEG BAG
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 7132947
• Report Number: 1018233-2017-06417
• Device Sequence Number: 11087888
• Product Code: KNX
• UDI-Device Identifier: 00801741050855
• UDI-Public: (01)00801741050855
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• 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): 03/01/2018

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: Health Professional
• Device Catalogue Number: 150719
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/28/2017
• Initial Date Received by Manufacturer: 11/28/2017
• Supplement Date Received by Manufacturer: 02/16/2018
• Initial Report FDA Received Date: 12/20/2017
• Supplement Report FDA Received Date: 03/01/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1