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

Model Number	150819
Medical Device Problem Code	Restricted Flow rate (1248)
Health Effect - Clinical Code	Urinary Tract Infection (2120)
Date of Event	01/27/2022
Type of Reportable Event	Serious Injury
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 leg bag was defective.It was noted that the patient had been using this product less than 90 days.Per follow up received on (b)(6) 2022, it was stated that the leg bag would not drain from upper chamber and the patient had two leg bags blow out because the urine would not drain.The patient experienced a urinary tract infection after the second blow out.The doctor prescribed patient an antibiotics for the urinary tract infection.
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 leg bag was defective.It was noted that the patient had been using this product less than 90 days.Per follow up received on (b)(6) 2022, it was stated that the leg bag would not drain from upper chamber and the patient had two leg bags blow out because the urine would not drain.The patient experienced a urinary tract infection after the second blow out.The doctor prescribed patient an antibiotics for the urinary tract infection.
Additional Manufacturer Narrative
The reported event is inconclusive as no sample was returned for evaluation.A potential root cause for this failure could be "obstruction in tube".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 was not returned for evaluation.The lot number is unknown; therefore, the device history record could not be reviewed.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).When using extension tubing, make sure to connect tube at least to the 3rd taper of the connector.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." the device was not returned.
Event or Problem Description
It was reported that the leg bag was defective.It was noted that the patient had been using this product less than 90 days.Per follow up received on 27jan2022, it was stated that the leg bag would not drain from upper chamber and the patient had two leg bags blow out because the urine would not drain.The patient experienced a urinary tract infection after the second blow out.The doctor prescribed patient an antibiotics for the urinary tract infection.

• Brand Name: LEG BAG
• 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: 13562067
• Report Number: 1018233-2022-00724
• Device Sequence Number: 4457007
• Product Code: FAQ
• UDI-Device Identifier: 00801741050879
• UDI-Public: (01)00801741050879
• 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): 05/25/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: 150819
• Device Catalogue Number: 150819
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/27/2022
• Supplement Date Received by Manufacturer: 05/26/2022
• Initial Report FDA Received Date: 02/18/2022
• Supplement Report FDA Received Date: 06/16/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: Required Intervention
• Patient Sex: Unknown