MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 LEG BAG WITH FLIP-FLO VALVE, NO STRAPS, 32 OZ., STERILE

Model Number	150632
Medical Device Problem Code	Restricted Flow rate (1248)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/20/2021
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.
Event or Problem Description
It was reported that the drain bag was not open enough to let the water in.It was further mentioned that the user tried to put the water in and it was piled over on the top.Per follow up call on (b)(6) 2021 it was stated that the drain bags had a problem with the flutter valve and was not allowing the water to pass through.
Additional Manufacturer Narrative
The reported event was unconfirmed because the reported failure could not be reproduced.The device met relevant specifications.The product had not caused the reported failure.Visual evaluation of the returned sample noted 3 opened (without original packaging), dispoz-a-bag.Visual inspection of the samples noted water was able to enter the flutter valve and drain with no issues.No root cause could be found because the reported event was unconfirmed.A dhr is not required since the reported failure was unconfirmed.As the reported event is unconfirmed a labeling review is not required.The actual/suspected device was evaluated.
Event or Problem Description
It was reported that the drain bag was not opening enough to let the water in.It was further mentioned that the user tried to put the water in, and it piled over on the top.Per follow-up call on 20may2021, it was reported that the drain bags that had a problem with the flutter valve and was not allowing the water to pass through.

• Brand Name: LEG BAG WITH FLIP-FLO VALVE, NO STRAPS, 32 OZ., STERILE
• Common Device Name: LEG BAG
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• Manufacturer (Section G): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• Manufacturer Contact: yonic anderson ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 11996458
• Report Number: 1018233-2021-03488
• Device Sequence Number: 3650859
• Product Code: FAQ
• UDI-Device Identifier: 00801741050848
• UDI-Public: (01)00801741050848
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/12/2021
• 2 Devices were Involved in the Event: 1 2

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: 09/30/2025
• Device Model Number: 150632
• Device Catalogue Number: 150632
• Device Lot Number: NGEW2258
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/15/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 05/20/2021
• Supplement Date Received by Manufacturer: 11/12/2021
• Initial Report FDA Received Date: 06/14/2021
• Supplement Report FDA Received Date: 12/02/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown