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

Model Number	150819
Medical Device Problem Codes	Restricted Flow rate (1248); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/12/2021
Type of Reportable Event	Malfunction
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.
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 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.
Additional Manufacturer Narrative
The reported event was inconclusive because no sample was returned.A potential root cause was not chosen due to a lack of information.The device was used for treatment, though it was unknown if the device was related to the reported event or met specifications since a sample was not returned.The lot number is unknown; therefore, the device history record could not be reviewed.A labeling review was not performed due to insufficient information.Correction: h.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.

• 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: 13561102
• Report Number: 1018233-2022-00720
• Device Sequence Number: 4313258
• 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): 04/01/2022

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 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: 04/01/2022
• Initial Report FDA Received Date: 02/18/2022
• Supplement Report FDA Received Date: 04/28/2022
• 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: Other
• Patient Sex: Unknown