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

Model Number PWFX30

Device Problems Biocompatibility (2886); Patient Device Interaction Problem (4001)

Patient Problems Pain (1994); Burning Sensation (2146); Swelling/ Edema (4577)

Event Date 02/10/2022

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 patient used the purewick urine collection system for ten days in the hospital with no issues.Patient just got the purewick urine collection system a few days ago.Patient believed they would be allergic to the gauze and was having vaginal burning, swelling and pain.Customer wanted to know what they need to use to treat reaction and stated that they had used lidocaine cream.Inquirer responded customer denied a latex allergy and confirmed that they used gauze before with no reaction.

Manufacturer Narrative

The reported event is inconclusive, due to representative sample.Potential cause of failure is inadequate materials selection/ materials of construction are not biocompatible.As the product is not sold sterile and the reported event was not related to sterilization, a sterilization record review is not required.The results of the dhr review did not show any problems or conditions that would have contributed to the reported issue.Based on the results of the investigation, no additional action is required at this time.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.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".Warnings: do not use the purewicktm female external catheter with bedpan or any material that does not allow for sufficient airflow.To avoid potential skin injury, never push or pull the purewicktm female external catheter against the skin during placement or removal.Never insert the purewicktm female external catheter into vagina, anal canal, or other body cavities.Discontinue use if an allergic reaction occurs.After use, this product may be a potential biohazard.Dispose of in accordance with applicable local, state and federal laws and regulations.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 actual/suspected device was inspected.

Event Description

It was reported that patient used the purewick urine collection system for ten days in the hospital with no issues.Patient just got the purewick urine collection system a few days ago.Patient believed they would be allergic to the gauze and was having vaginal burning, swelling and pain.Customer wanted to know what they need to use to treat reaction and stated that they had used lidocaine cream.Inquirer responded customer denied a latex allergy and confirmed that they used gauze before with no reaction.

• 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: juan velez ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 13686306
• MDR Text Key: 286746403
• Report Number: 1018233-2022-01085
• 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: 08/19/2022

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 Expiration Date: 08/28/2023
• Device Model Number: PWFX30
• Device Catalogue Number: PWFX30
• Device Lot Number: MYFU1478
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/10/2022
• Initial Date FDA Received: 03/08/2022
• Supplement Dates Manufacturer Received: 08/19/2022
• Supplement Dates FDA Received: 08/22/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/24/2021
• 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