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

Model Number PWFX30

Device Problem Device Handling Problem (3265)

Patient Problem Urinary Tract Infection (2120)

Event Date 03/07/2023

Event Type  Injury  

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 these purewick female external catheters caused urinary tract infection, but the patient thought it was because they were not changing it very often.It was noted that the patient had been using the purewick products for less than 90 days.It was unknown what medical intervention was provided.Per clarification mail received on 09mar2023, stated that it seems like the patient was wearing the wick longer than recommended.

Manufacturer Narrative

The reported issue was confirmed as use related issue as the patient used the wick more than 12 hours.A potential root cause for this failure could be due to ¿user unaware of time limitation or forgets the patient is using the device.".It was unknown whether the device had met specifications.The product was used for treatment purposes.The failure was caused by the misuse of the product.A dhr review was not required because the investigation was confirmed as use related.The instructions for use were found adequate and state the following: "maintenance: replace the purewicktm female external catheter at least every 8-12 hours or if soiled with feces or blood.Always assess skin for compromise and perform perineal care prior to placement of a new purewicktm female external catheter." precautions: not recommended for patients who are: experiencing skin irritation or breakdown at the site.Warnings: discontinue use if an allergic reaction occurs.Recommendations: assess device placement and patient¿s skin at least every 2 hours.Replace the purewicktm female external catheter every 8-12 hours or when soiled with feces or blood." 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 these purewick female external catheters caused urinary tract infection, but the patient thought it was because they were not changing it very often.It was noted that the patient had been using the purewick products for less than 90 days.It was unknown what medical intervention was provided.Per clarification mail received on 09mar2023, stated that it seems like the patient was wearing the wick longer than recommended.

• 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: xeeroy rada ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 16626779
• MDR Text Key: 312114022
• Report Number: 1018233-2023-02081
• 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,Consumer
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 05/25/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: PWFX30
• Device Catalogue Number: PWFX30
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/07/2023
• Initial Date FDA Received: 03/28/2023
• Supplement Dates Manufacturer Received: 05/25/2023
• Supplement Dates FDA Received: 06/06/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Other
• Patient Sex: Female