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

Model Number	150732
Medical Device Problem Codes	Component Missing (2306); Component Misassembled (4004)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/13/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that there was no tubing for the leg bag.The patient had been using less than 90 days.
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 unconfirmed because the device meets specifications.No root cause could be found because the reported event was unconfirmed.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.A labeling review was not performed because labeling could not have prevented the reported failure.The actual/suspected device was inspected.
Event or Problem Description
It was reported that there was no tubing for the leg bag.The patient had been using less than 90 days.Per follow up information received on 25jan2022, customer stated that they had received two leg bags without the tubing and the replacement tubing that was sent to them did not seemed like the tubing that typically came with the leg bag.

• Brand Name: LEG BAG WITH FLIP-FLO VALVE, FABRIC LEG STRAPS, 32 OZ., STERILE
• Common Device Name: DRAIN 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: 12760656
• Report Number: 1018233-2021-06989
• Device Sequence Number: 16977441
• Product Code: FAQ
• UDI-Device Identifier: 00801741050862
• UDI-Public: (01)00801741050862
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 04/30/2022

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: 07/31/2026
• Device Model Number: 150732
• Device Catalogue Number: 150732
• Device Lot Number: NGFU1913
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/13/2021
• Supplement Date Received by Manufacturer: 04/30/2022
• Initial Report FDA Received Date: 11/07/2021
• Supplement Report FDA Received Date: 05/23/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/02/2021
• 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