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

Model Number	150419
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/01/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a visiting nurse checked the actual product for a patient at home and confirmed that the urination port of the leg bag was distorted and could not be used.Per follow up information received on (b)(6) 2022, there was no impact on patient and looked like there was no bent and twisted from the photo samples.
Additional Manufacturer Narrative
The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.
Additional Manufacturer Narrative
The reported event was confirmed cause unknown.1 sample was confirmed to exhibit the reported failure.The device had not met specifications.It is unknown if the product was used for treatment.The product caused the reported failure.Visual evaluation of the returned sample noted one opened (with original packaging), used dispoz-a-bag.Visual inspection of the sample noted the flip-flo valve bend/ distorted.The photo sample provided shows the flip-flo valve bend/ distorted.This does not meet specification which states "damages are not allowed in the components".A potential root cause for this failure mode could be ¿inappropriate package design¿.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.Pull 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 (catalog no.150615 or 4a4194).4.To empty dispoz-a-bag, push green lever on flip-flo valve out and down.Important: be sure to reclose flip-flo valve after emptying bag.5.After use, this product may be a potential biohazard.Handle and dispose of in accordance with accepted medical practice and applicable, local, state and federal laws and regulations.Bard dispoz-a-bag accessories: ¿ leg bag holder ¿ 1-3/4¿ wide leg bag strap ¿ deluxe fabric leg bag straps ¿ extension tubing" the actual/suspected device was inspected.
Event or Problem Description
It was reported that a visiting nurse checked the actual product for a patient at home and confirmed that the urination port of the leg bag was distorted and could not be used.Per follow up information received on 08aug2022, there was no impact on patient and looked like there was no bent and twisted from the photo samples.

• Brand Name: LEG BAG WITH FLIP-FLO VALVE
• 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: xeeroy rada ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 15233982
• Report Number: 1018233-2022-06437
• Device Sequence Number: 4692967
• Product Code: FAQ
• UDI-Device Identifier: 00801741080654
• UDI-Public: (01)00801741080654
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/01/2023

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: 05/31/2026
• Device Model Number: 150419
• Device Catalogue Number: 150419
• Device Lot Number: NGFS4410
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/09/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/02/2022
• Supplement Date Received by Manufacturer: 02/01/2023
• Initial Report FDA Received Date: 08/16/2022
• Supplement Report FDA Received Date: 02/01/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/18/2021
• 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