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 03/13/2023

Event Type  malfunction  

Event Description

It was reported that the purewick urine collection system was not suctioning and was leaking.Representative did troubleshoot water cup test and machine failed.Patient had been using the purewick product for less than 90 days.Per additional information received via liberator on 13mar2023, stated that the machine was smoking and it had a bad smell.Representative advised to replace the kit and the patient said they already replaced it.Customer service found that the replacement was issued on december to the patient from the liberator.It was noted that the patient had been using the purewick products for less than 90 days.Per clarification mail received from liberator on 21mar2023, confirmed that the bad smell refers to the smoking smell.

Manufacturer Narrative

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

Manufacturer Narrative

The reported event was inconclusive because no sample was returned.A potential root cause for this failure could be "inadequate component selection component failures, damage, or deterioration ".It was unknown whether the device had met relevant specifications.The dhr review could not be performed without a lot number.The instructions for use were found adequate and states the following: replacing canister and tubing: replace the canister and tubing for each patient per facility protocol or at least every 60 days, whichever is sooner.If you notice any of the following, replace immediately: canister or tubing has residual urine build-up canister or tubing appear cloudy.Canister or tubing appear discolored.Canister becomes cracked.Tubing becomes torn.Purewick¿ external catheter no longer securely connects to collector tubing failure to clean and/or replace accessories may affect the performance of the system.The useful life of the collection canister and tubing is 60 days.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.

Event Description

It was reported that the purewick urine collection system was not suctioning and was leaking.Representative did troubleshoot water cup test and machine failed.Patient had been using the purewick product for less than 90 days.As per additional information received via liberator on 13mar2023, stated that the machine was smoking and it had a bad smell.Representative advised to replace the kit and the patient said they already replaced it.Customer service found that the replacement was issued on december to the patient from the liberator.It was noted that the patient had been using the purewick products for less than 90 days.As per clarification mail received from liberator on 21mar2023, confirmed that the bad smell refers to the smoking smell.

• 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: 16663097
• MDR Text Key: 313413844
• Report Number: 1018233-2023-02248
• 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: 06/15/2023

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/13/2023
• Initial Date FDA Received: 04/03/2023
• Supplement Dates Manufacturer Received: 06/15/2023
• Supplement Dates FDA Received: 06/19/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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