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

Catalog Number	PWFX30
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Pressure Sore/Ulcer (2326)
Date of Event	03/11/2026
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 auth advised sometimes there is leaking and sometimes they go a few weeks with no leaking.Patient has to lie on side due to bed sores.Nurse advised on tips.It is unclear if the lot number was requested.No medical intervention or patient impact reported.No additional information provided.
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: instruction for use: peri care and placement: 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 purewick 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 purewick female external catheter is positioned.Maintenance: replace the purewick female external catheter at least every 8 to 12 hours or if soiled with feces or blood.Always assess skin for compromise and perform perineal care prior to placement of a new purewick female external catheter.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.Warnings: discontinue use if an allergic reaction occurs.Precautions: do not use barrier cream on the perineum when using the purewick female external catheter.Barrier cream may impede suction.Recommendations: ensure the purewick female external catheter remains in the correct position after turning the patient.Remove the purewick female external catheter prior to ambulation.Properly placing the purewick female external catheter snugly between the labia and gluteus holds the purewick female external catheter in place for most patients.Mesh underwear may be useful for securing the purewick female external catheter for some patients.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.A dhr could not be performed since no lot number was provided.No additional actions can be taken at this time.Corrections: a, b.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.
Event or Problem Description
It was reported that the authority advised sometimes there is leaking and sometimes they go a few weeks with no leaking.Patient has to lie on side due to bed sores.Nurse advised on tips.It is unclear if the lot number was requested.No medical intervention or patient impact reported.No additional information provided.

• Brand Name: PUREWICK FEMALE EXTERNAL CATHETER
• Common Device Name: PUREWICK FEMALE CATHETER
• 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: 24595853
• Report Number: 1018233-2026-01722
• Device Sequence Number: 8689046
• Product Code: NZU
• UDI-Device Identifier: 00801741189050
• UDI-Public: (01)00801741189050
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): 04/08/2026

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?: Yes
• 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: 03/11/2026
• Supplement Date Received by Manufacturer: 04/08/2026
• Initial Report FDA Received Date: 03/13/2026
• Supplement Report FDA Received Date: 04/10/2026
• 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