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

Model Number PW200

Device Problem Overheating of Device (1437)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/23/2023

Event Type  malfunction  

Event Description

It was reported that three days after receiving new purewick urine collection system it burnt out and will not turn on.Patient had been using the purewick product for more than 90 days.

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 three days after receiving new purewick urine collection system it burnt out and would not turn on.Patient had been using the purewick product for more than 90 days.

Manufacturer Narrative

The reported event is unconfirmed, as the event could not be reproduced.A bd purewick urine collection system, pump tubing, collector tubing with elbow connector, collection canister with lid, and were returned.In-house external power cord use for analysis.There were no cracks present.There was no residue present.The stop valve was working properly.There was light and sound indicating function.The device did meet relevant specifications.The product was used for treatment purposes.The product did not cause the reported failure.As the reported event is unconfirmed, dhr review is not required.As the reported event is unconfirmed, a labeling/packing review is not required.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.

• 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
• Manufacturer (Section G): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• Manufacturer Contact: xeeroy rada ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 16345560
• MDR Text Key: 309281429
• Report Number: 1018233-2023-00767
• Device Sequence Number: 1
• Product Code: NZU
• UDI-Device Identifier: 00801741185359
• UDI-Public: (01)00801741185359
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Consumer
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/12/2023

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
• Device Operator: Lay User/Patient
• Device Model Number: PW200
• Device Catalogue Number: PW200
• Device Lot Number: BMGQPX05
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/23/2023
• Initial Date FDA Received: 02/10/2023
• Supplement Dates Manufacturer Received: 04/13/2023
• Supplement Dates FDA Received: 04/14/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/11/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Sex: Female