MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 LEG BAG WITH RUBBER CAP VALVE (ONE PAIR OF LATEX STRAPS), 32OZ., STERILE

Catalog Number	150103
Medical Device Problem Code	Restricted Flow rate (1248)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was not returned for evaluation.A potential failure mode could be 'valve lever does not open or function properly¿ with a potential root cause of 'improper tolerance (fit between the valve body and valve lever).Improper dimension of lever inner diameter.Distortion of the lever due to exposure to high temperatures for an extended period of time.¿ 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: "directions for use: 1.Separate notches within circles.Put straps through holes and around leg.2.Position bag on leg with flutter valve at top.3.Attach catheter or extension tubing to top inlet.When wearing bag below knee, attach bard extension tubing.4.To empty dispoz-a-bag leg bag, remove cap at bottom.Important: hold green connector firmly while removing cap.".
Event or Problem Description
It was reported that the flutter valve did not allow urine to drain through the tube into the bag.

• Brand Name: LEG BAG WITH RUBBER CAP VALVE (ONE PAIR OF LATEX STRAPS), 32OZ., STERILE
• Common Device Name: LEG BAG
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 9173181
• Report Number: 1018233-2019-06381
• Device Sequence Number: 2323619
• Product Code: KNX
• UDI-Device Identifier: 00801741050732
• UDI-Public: (01)00801741050732
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 10/09/2019

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: 03/31/2024
• Device Catalogue Number: 150103
• Device Lot Number: NGDQ0561
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/17/2019
• Initial Report FDA Received Date: 10/09/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1