MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 PUREWICK URINE COLLECTION SYSTEM

Model Number PW100

Device Problem Disconnection (1171)

Patient Problem Urinary Tract Infection (2120)

Event Date 03/16/2021

Event Type  Injury  

Manufacturer Narrative

The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.

Event Description

It was reported that the purewick urine collection system had not been working properly due to the power cord not staying connected, and patient thought this had caused patient to had a urinary tract infection.It was unknown if the device contributed to the urinary tract infection at this time and medical intervention is unknown.

Manufacturer Narrative

The reported event was unconfirmed as the reported failure could not be reproduced and the root cause was unknown.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.As the reported event was unconfirmed, a labeling review was not required.H11:section a through f - the information provided by bd 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 bd.H3 other text : the actual/suspected device was inspected.

Event Description

It was reported that the purewick urine collection system had not been working properly due to the power cord not staying connected, and patient thought this had caused patient to had a urinary tract infection.It was unknown if the device contributed to the urinary tract infection at this time and medical intervention is unknown.

• Brand Name: PUREWICK URINE COLLECTION SYSTEM
• Type of Device: PUREWICK URINE COLLECTION SYSTEM
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• MDR Report Key: 11641109
• MDR Text Key: 244632932
• Report Number: 1018233-2021-02016
• Device Sequence Number: 1
• Product Code: NZU
• UDI-Device Identifier: 00801741185342
• UDI-Public: (01)00801741185342
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Type of Report: Initial,Followup
• Report Date: 09/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/09/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 09/14/2021
• Device Model Number: PW100
• Device Catalogue Number: PW100
• Device Lot Number: BMDYPX02
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/10/2021
• Date Manufacturer Received: 09/02/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other