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

Model Number PW200

Device Problem Illegible Information (4050)

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

Event Date 01/11/2023

Event Type  malfunction  

Manufacturer Narrative

The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.The device was not returned.

Event Description

It was reported that the patient was having leaking issues with the purewick female external catheter.Liberator representative performed a half troubleshoot.It was noted that patient had been using products for less than 90 days.Per follow-up via phone on (b)(6) 2022, it was reported that patient had placement issues with the wicks.They also inquired about a refund, so bd person referred back to lms for refund questions and options and troubleshooting for proper wick placement.Per follow up by liberator via phone on (b)(6) 2022, it was stated that the patient was getting wet.The representative advised the patient on wick adjustment and placement.The patient stated that they would try again.Per additional information received via liberator on 11-jan-2023, stated that the purewick urine collection system was blinking and wanted to know why.Patient just came from rehabilitation and was just setting up the system and also stated that the pamphlet did not list what the light means but the patient did not look under battery.Representative explained patient what each light indicates.It was noted that the patient had been using the purewick products for more than 90 days.

Manufacturer Narrative

Upon further review, bd has determined that this mdr event is not reportable.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 device was not returned.

Event Description

It was reported that the patient was having leaking issues with the purewick female external catheter.Liberator representative performed a half troubleshoot.It was noted that patient had been using products for less than 90 days.As per follow-up via phone on (b)(6) 2022, it was reported that patient had placement issues with the wicks.They also inquired about a refund so bd person referred back to lms for refund questions and options and troubleshooting for proper wick placement.As per follow up by liberator via phone on (b)(6) 2022, it was stated that the patient was getting wet.The representative advised the patient on wick adjustment and placement.The patient stated that they would try again.As per additional information received via liberator on 11jan2023, stated that the purewick urine collection system was blinking and wanted to know why.Patient just came from rehabilitation and was just setting up the system and also stated that the pamphlet did not list what the light means but the patient did not look under battery.Representative explained patient what each light indicates.It was noted that the patient had been using the purewick products for more than 90 days.

• 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: 16265785
• MDR Text Key: 308404147
• Report Number: 1018233-2023-00430
• 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: 06/05/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/30/2023
• 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
• Date Manufacturer Received: 06/05/2023
• 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