MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 BARD URINARY DRAINAGE BAG WITH ANTI-REFLUX CHAMBER

Model Number	N154002
Medical Device Problem Codes	Device Damaged Prior to Receipt by User (1570); Component Misassembled (4004)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/12/2021
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.
Event or Problem Description
It was reported that the foley catheter came out of the pack.It was sealed shut and not able to empty the bag.
Event or Problem Description
It was reported that the foley catheter came out of the pack.It was sealed shut and not able to empty the bag.
Additional Manufacturer Narrative
The reported event was inconclusive.It was unknown whether the device had met specifications.The product was used for treatment purposes.It was unknown whether the product had caused the reported failure.No sample was returned for evaluation.A potential root cause for this failure could be due to "incorrect part orientation/placement design".The device was not returned for evaluation.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 bard represents all of 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 bard.

• Brand Name: BARD URINARY DRAINAGE BAG WITH ANTI-REFLUX CHAMBER
• Common Device Name: URINARY DRAINAGE BAG
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• MDR Report Key: 11290516
• Report Number: 1018233-2021-00298
• Device Sequence Number: 14642528
• Product Code: KNX
• UDI-Device Identifier: 10801741046787
• UDI-Public: (01)10801741046787
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/03/2021

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: 05/31/2025
• Device Model Number: N154002
• Device Catalogue Number: N154002
• Device Lot Number: NGES4314
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/12/2021
• Supplement Date Received by Manufacturer: 06/03/2021
• Initial Report FDA Received Date: 02/07/2021
• Supplement Report FDA Received Date: 06/25/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other