MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 LEG BAG WITH FLIP-FLO VALVE, FABRIC LEG STRAPS, 32 OZ., STERILE

Model Number	150732
Medical Device Problem Code	Nonstandard Device (1420)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/20/2023
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 device was not returned.
Event or Problem Description
It was reported that the leg bag slides down to their leg and crinkle the bag and in turn, urine did not flow into the bag.
Event or Problem Description
It was reported that the leg bag slides down to their leg and crinkle the bag and in turn, urine did not flow into the bag.
Additional Manufacturer Narrative
The reported event was inconclusive because no sample was returned.A potential root cause for this failure could be ¿velcro strength is not sufficient¿.It is unknown whether the device had met relevant specifications.The product was used for treatment purposes.It was unknown whether the product had caused the reported failure.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: "deluxe fabric leg straps for dispoz-a-bag® disposable urine bags ¿ comfortable and secure ¿ washable ¿ reusable, single patient directions for use: 1.Insert soft loop-pad end of strap through strap slits on leg bag, so that straps run behind bag, and loop-pad faces bag.2.Wrap straps around leg, either on thigh or calf.(if straps are too long, remove leg bag.Cut straps at separations between loop-pads, only, to achieve desired length.) 3.Locate leg bag on inside of leg and connect strap ends by pressing together.Straps must fit snugly, but must be comfortable.Washing instructions: do not use bleach.Wash in warm water." h11: section a through f - the information provided by bd represents all 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 bd.H3 other text : the device was not returned.

• Brand Name: LEG BAG WITH FLIP-FLO VALVE, FABRIC LEG 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: xeeroy rada ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 16706896
• Report Number: 1018233-2023-02404
• Device Sequence Number: 3585034
• Product Code: FAQ
• UDI-Device Identifier: 00801741050862
• UDI-Public: (01)00801741050862
• Combination Product (Y/N): N
• Initial Reporter State: AK
• 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,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/30/2023

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 Model Number: 150732
• Device Catalogue Number: 150732
• Device Lot Number: NGGV0802
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/20/2023
• Supplement Date Received by Manufacturer: 05/30/2023
• Initial Report FDA Received Date: 04/10/2023
• Supplement Report FDA Received Date: 05/31/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/16/2022
• 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