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

Model Number	154004A
Medical Device Problem Codes	Device Contamination with Chemical or Other Material (2944); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/07/2021
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 there was no urine flow, and the customer found a foreign object attached to the drain bag filter area on the day of placement.The customer peeled it off and urine flowed.No abnormalities had been observed upon visual inspection.
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.The product was used for patient treatment.The product had caused the reported failure.Visual evaluation of the returned sample noted one opened (without original packaging), used dome bag.Visual inspection of the sample noted there was no foreign material present on the drainage bag, but there was damage to the filter, and there was an outline of adhesive residue around the filter giving supporting evidence of the reported event.A potential root cause for this failure could be defective /contaminated components from supplier.A review of the device history record did not show any problems or conditions that would have contributed to the reported issue.The investigation is concluded, and no additional action is required at this time.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.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 actual/suspected device was inspected.
Event or Problem Description
It was reported that there was no urine flow, and the customer found a foreign object attached to the drain bag filter area on the day of placement.The customer peeled it off and urine flowed.No abnormalities had been observed upon visual inspection.

• Brand Name: BARD® URINARY DRAINAGE BAG
• Common Device Name: DRAINAGE 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: 12541542
• Report Number: 1018233-2021-06057
• Device Sequence Number: 11072818
• Product Code: KNX
• UDI-Device Identifier: 00801741029554
• UDI-Public: (01)00801741029554
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/23/2022

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: Health Professional
• Device Expiration Date: 10/28/2024
• Device Model Number: 154004A
• Device Catalogue Number: 154004A
• Device Lot Number: MYFQ1341
• 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: 09/08/2021
• Supplement Date Received by Manufacturer: 02/23/2022
• Initial Report FDA Received Date: 09/28/2021
• Supplement Report FDA Received Date: 03/18/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/29/2021
• 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