MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 PUREWICK FEMALE EXTERNAL CATHETER

Model Number PWFX30

Device Problem Material Separation (1562)

Patient Problems Rash (2033); Urinary Tract Infection (2120)

Event Date 10/18/2021

Event Type  Injury  

Event Description

It was reported that the purewick female external catheters were defective and came apart.Per customer via phone on (b)(6) 2021, stated they had stopped using the system due to rash and bad urinary tract infection.Also described the rash was just being red and would be seeing the doctor later this week.The patient also developed a bad urinary tract infection, was hospitalized and on antibiotics both by injection and intravenous (iv).Stated that patient also had home health come to administer antibiotics and was getting better.Physician advised the patient to stop using the system until they could get better wicks.Stated that the wicks came apart once they got wet and the patient believed that was causing the rash.Also described the white cotton section was coming out of the blue section.Medical intervention was reported.

Manufacturer Narrative

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

Manufacturer Narrative

The reported event was inconclusive as no sample returned for evaluation.A potential root cause for this failure mode could be due to operator error or mishandling.It was unknown whether the device had met specifications.The product was used for treatment but it was unknown whether the product had caused the reported failure.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.The labeling review was not required due to the labeling could not prevent the reported issue.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 purewick female external catheters were defective and came apart.Per customer via phone on 09nov2021: it was stated that the patient had stopped using the system due to rash and bad urinary tract infection.Also described the rash was just being red and would be seeing the doctor later in the week.The patient also developed a bad urinary tract infection and was hospitalized and on antibiotics both by injection and intravenous (iv).It was stated that the patient also had home health come to administer the antibiotics and was getting better.The physician advised the patient to stop using the system until they could get better wicks.Also stated that the wicks came apart once they got wet and the patient believed that was caused the rash.Also described the white cotton section was coming out of the blue section.Medical intervention was reported.

• Brand Name: PUREWICK FEMALE EXTERNAL CATHETER
• Type of Device: PUREWICK FEMALE EXTERNAL CATHETER
• 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: yonic anderson ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 12902707
• MDR Text Key: 281496742
• Report Number: 1018233-2021-07627
• Device Sequence Number: 1
• Product Code: NZU
• UDI-Device Identifier: 00801741189050
• UDI-Public: (01)00801741189050
• 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,Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 12/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/30/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 02/28/2023
• Device Model Number: PWFX30
• Device Catalogue Number: PWFX30
• Device Lot Number: MYFQ0051
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/21/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/24/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Sex: Female