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

Model Number	154004A
Medical Device Problem Code	Component Misassembled (4004)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/18/2022
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.
Event or Problem Description
It was reported that the urine leaked from the connecting part between the drain bag and the urination port on the 4th day of placement.Per sample evaluation from investigator via email on 18jan2022, it was confirmed that based on the second sample evaluation there was pvc material between the inlet tubing and the dome.Per additional information received on 26jan2022, there were no leaks found during sample evaluation.However, during further evaluation, it was noted that there was pvc material between the inlet tubing and the dome.
Additional Manufacturer Narrative
The reported event was confirmed as supplier related.The device had not met specifications.The product was used for 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 noted no obvious visible observations.The drain bag was filled with methylene blue solution (3 drops 1% aq methylene blue per 100ml distilled water), and was allowed to rest with no observed leaks.Upon further inspection, there was a piece of pvc material present in the dome.Verified dome cavity.This is out of specification per inspection procedure, which states, "there shall be no occlusion of the i.D.Of the inlet port, verify with pin gage" a potential root cause for this failure could be inspection results (measurement, testing data) not verified by iqa assignee.The lot number was unknown; therefore, the device history record could not be reviewed.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 the urine leaked from the connecting part between the drain bag and the urination port on the 4th day of placement.Per sample evaluation from investigator via email on 18jan2022, it was confirmed that based on the second sample evaluation there was pvc material between the inlet tubing and the dome.Per additional information received on 26jan2022, there were no leaks found during sample evaluation.However, during further evaluation, it was noted that there was pvc material between the inlet tubing and the dome.

• 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: 13480950
• Report Number: 1018233-2022-00474
• Device Sequence Number: 14799591
• 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): 06/03/2022

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 Model Number: 154004A
• Device Catalogue Number: 154004A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/27/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/18/2022
• Supplement Date Received by Manufacturer: 06/03/2022
• Initial Report FDA Received Date: 02/08/2022
• Supplement Report FDA Received Date: 06/23/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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