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

Model Number PWFX30

Device Problem Malposition of Device (2616)

Patient Problem Unspecified Infection (1930)

Event Date 10/15/2021

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that the patient moved through the night and got wet using purewick female external catheter.The representative provided wick preparation and placement instructions.It was noted that the patient had been using the pure wick products for 1 week.Per customer via phone on (b)(6) 2022, it was stated that customer stopped using the catheter months ago because it caused skin infections.The doctor treated the skin infections and told them not to use purewick.It took a long time to heal the skin infection.Also stated that the customer did not have any issues using the industrial grade system at the hospital because the suction was stronger and the home system suction was not strong enough and customer had to wear garments over the wick.It was unknown what medical intervention was provided for skin infection.

Manufacturer Narrative

The reported event is confirmed use related.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 "patient combative or uncooperative or the user is unaware of the necessary movement restrictions".A dhr review was not required because the investigation was confirmed - use related.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" 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 patient moved through the night and got wet using purewick female external catheter.The representative provided wick preparation and placement instructions.It was noted that the patient had been using the pure wick products for 1 week.Per customer via phone on (b)(6) 2022, it was stated that customer stopped using the catheter months ago because it caused skin infections.The doctor treated the skin infections and told them not to use purewick.It took a long time to heal the skin infection.Also stated that the customer did not have any issues using the industrial grade system at the hospital because the suction was stronger and the home system suction was not strong enough and customer had to wear garments over the wick.

• 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: 13443480
• MDR Text Key: 285938466
• Report Number: 1018233-2022-00364
• 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: 05/23/2024

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: 01/13/2022
• Initial Date FDA Received: 02/03/2022
• Supplement Dates Manufacturer Received: 11/10/2021
• Supplement Dates FDA Received: 05/28/2024
• Was Device Evaluated by Manufacturer?: No
• 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; Other
• Patient Sex: Female