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

Model Number PWFX30

Device Problems Malposition of Device (2616); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Urinary Tract Infection (2120)

Event Date 03/11/2022

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 the patient had stopped using the purewick female external catheters because of urinary tract infections (uti)¿s.It was noted that patient had been using products for less than 90 days.It was unknown if the device contributed to the urinary tract infections at this time and medical intervention was unknown.

Event Description

It was reported that the patient had stopped using the purewick female external catheters because of urinary tract infections (uti)¿s.It was noted that patient had been using products for less than 90 days.It was unknown if the device contributed to the urinary tract infections at this time and medical intervention was unknown.Per follow up information received on 25apr2022, customer reported that they were not using it correctly and that lead to the problems they were having.Also stated that they want help to get the catheter in place.They were no longer using the purewick urine collection system.

Manufacturer Narrative

The reported issue was confirmed as use related issue as per the reported event and ifu.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.No sample was returned for evaluation.A potential root cause for the issue could be "user attention failure, places device incorrectly or is unaware of the proper placement of the device." the device history record review was not required as the investigation was confirmed as use related and the lot number was unknown.The instructions for use were found adequate and state the following: "perform perineal care and assess skin integrity (document per hospital protocol).Separate legs, gluteus muscles, and labia.Palpate pubic bone as anatomical marker.With soft gauze side facing patient, align distal end of the purewicktm female external catheter at gluteal cleft.Gently tuck soft gauze side between separated gluteus and labia.Ensure that the top of the gauze is aligned with the pubic bone.Slowly place legs back together once the purewicktm female external catheter is positioned".Note: patient can be positioned on back, side lying, frog legged, or lying on back with knees bent and thighs apart (lithotomy position) prior to device placement.Not recommended for patients who are: agitated, combative, or uncooperative and might remove the purewicktm female external catheter".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.

• 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: 14021664
• MDR Text Key: 288668431
• Report Number: 1018233-2022-02020
• 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: 05/26/2022

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: 03/11/2022
• Initial Date FDA Received: 04/06/2022
• Supplement Dates Manufacturer Received: 05/26/2022
• Supplement Dates FDA Received: 06/15/2022
• 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