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

Catalog Number	PWFX30
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	03/31/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.Udi format updated with available product information per gudid.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.
Event or Problem Description
It was reported that the customer states the pw system is working fine but wants to know if we have address the issue with the pw system causing bladder infections.Rep explained we have not had any reported issues pertaining any infections.Advised she contact her doctor regarding this, she states she has and is on antibiotics.Also asked if she has been replacing the wicks every 8 hours and she stated she has been doing so; no supplies has been purchased from us since 2024 per order history.Unclear if medical intervention was provided.It's unclear if lot number was requested.No additional information provided.No troubleshooting was provided.(prepping and placement tips shared).
Event or Problem Description
It was reported that the customer states the pw system is working fine but wants to know if we have addressed the issue with the pw system causing bladder infections.Rep explained we have not had any reported issues pertaining any infections.Advised she contact her doctor regarding this, she states she has and is on antibiotics.Also asked if she has been replacing the wicks every 8 hours and she stated she has been doing so; no supplies has been purchased from us since 2024 per order history.Unclear if medical intervention was provided.It's unclear if lot number was requested.No additional information provided.No troubleshooting was provided.(prepping and placement tips shared).
Additional Manufacturer Narrative
The reported event was inconclusive because this investigation did not result in any additional findings and no sample was available for evaluation.The reported event is addressed within the labeling as it states: warnings: to avoid potential skin injury, never push or pull the purewick female external catheter against the skin during placement or removal.Never insert the purewick 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.Precautions: precautions: not recommended for patients who are:.Agitated, combative, or uncooperative and might remove the purewick female external catheter.Having frequent episodes of bowel incontinence without a fecal management system in place.Experiencing skin irritation or breakdown at the site.Experiencing moderate or heavy menstruation and cannot use a tampon do not use barrier cream on the perineum when using the purewick female external catheter.Barrier cream may impede suction.Proceed with caution in patients who have undergone recent surgery of the external urogenital tract.Always assess skin for compromise and perform perineal care prior to placement of a new purewick female external catheter.Maintain suction until the purewick female external catheter is fully removed from the patient to avoid urine backflow.Recommendations: assess device placement and patient¿s skin at least every 2 hours.Replace the purewick female external catheter every 8 to 12 hours or when soiled with feces or blood.Change suction tubing per hospital protocol or at least every thirty (30) days.A dhr could not be performed since no lot number was provided.No additional actions can be taken at this time.Corrections: a, d, f, h.Udi format updated with available product information per gudid.H11: sections 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.

• Brand Name: PUREWICK FEMALE EXTERNAL CATHETER
• Common Device Name: PUREWICK
• Manufacturer (Section D): C.R. BARD INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• Manufacturer (Section G): C.R. BARD INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• Manufacturer Contact: xeeroy rada ; 8195 industrial blvd; covington, GA 30014 ; 7707846100
• MDR Report Key: 24781652
• Report Number: 1018233-2026-02221
• Device Sequence Number: 13270970
• Product Code: NZU
• UDI-Device Identifier: 00801741189050
• UDI-Public: (01)00801741189050
• Combination Product (Y/N): N
• Initial Reporter State: HI
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/20/2026

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
• Operator of Device: Lay User/Patient
• Device Catalogue Number: PWFX30
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/31/2026
• Supplement Date Received by Manufacturer: 04/20/2026
• Initial Report FDA Received Date: 04/03/2026
• Supplement Report FDA Received Date: 04/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female