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

Model Number PW100

Device Problems Inadequate or Insufficient Training (1643); Misassembly by Users (3133)

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

Event Date 02/21/2021

Event Type  malfunction  

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 patient just did not know how to use the purewick urine collection system.It was noted that pw100 and pwfx30 were provided to the patient.Liberator medical service recommended patient to visit the purewick at home website for use instructions.

Manufacturer Narrative

Per follow up information received, it has been determined that this is not a reportable event.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.H3 other text : the device was not returned.

Event Description

It was reported that the patient just did not know how to use the purewick urine collection system.It was noted that pw100 and pwfx30 were provided to the patient.Liberator medical service recommended patient to visit the purewick at home website for use instructions.Per additional information received via phone on 01apr2021 customer was little confused when using the system for the first time because it would run continuously, as opposed to the one at the hospital that would only run when voiding the bladder.The customer noted that the motor was running but there was no suction.Per additional information received via phone on 02apr2021 customer service team followed up with the patient and conducted troubleshooting, hose were connected, valve reset, lid sealed, no damage to the canister and also conducted water test this resolved the issue.Representative also provided wick prepping and placement instructions.Also advised the patient that the accessories were due for replacement however, patient declined to reorder accessories at this time and would replace them with next reorder of wicks.

• 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: 11496386
• MDR Text Key: 240121793
• Report Number: 1018233-2021-01311
• 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: 04/19/2021

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
• Device Operator: Lay User/Patient
• Device Model Number: PW100
• Device Catalogue Number: PW100
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/21/2021
• Initial Date FDA Received: 03/16/2021
• Supplement Dates Manufacturer Received: 04/01/2021
• Supplement Dates FDA Received: 04/20/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other