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

Catalog Number	PWF030KX
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Tissue Breakdown (2681); Blister (4537)
Date of Event	09/13/2025
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.Initial reporter name: (b)(6).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 patient noted with multiple blisters intact and some burst causing open areas to bilateral lower buttocks and perineum area.It caused immobility, incontinence - stool, incontinence - urine, pressure to skin/tissue, skin moisture.Treatment provided such as purewick removed, site care performed, moisture barrier cream applied.Per follow up actions performed on (b)(6) 2025 suspect purewick injury, moisture barrier cream applied, and wound care consulted.Recommended to change and monitor skin under purewick every shift and prn.Ensure appropriate placement of purewick location.
Additional Manufacturer Narrative
The reported event was confirmed, cause unknown.Evaluation of the sample noted: a photo sample was returned of patient wound.Patient appeared to have blisters.The labeling is found to be adequate, as it states: to avoid potential skin injury, never push or rub the product against the skin during placement or removal.Do not block airflow to the product (e.G., blocking the vent hole, bedpan, barrier creams).Do not insert the product into vagina, anus, or other body orifice.Stop 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.Do not use on users with frequent episodes of stool incontinence without a fecal management system in place.Do not use on users with skin irritation or breakdown at the site.Use with caution on users who had recent surgery of the external female anatomy.Do not use on users with moderate/heavy menstruation who cannot use a tampon.Instructions also state: reposition the product and check the user¿s skin at least every 2 hours or per hospital protocol.A dhr review is not required as the lot number is unknown.No actions can be taken at this time.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 patient noted with multiple blisters intact and some burst causing open areas to bilateral lower buttocks and perineum area.It caused immobility, incontinence - stool, incontinence - urine, pressure to skin/tissue, skin moisture.Treatment provided such as purewick removed, site care performed, moisture barrier cream applied.Per follow up actions performed on (b)(6) 2025 suspect purewick injury, moisture barrier cream applied, and wound care consulted.Recommended to change and monitor skin under purewick every shift and prn.Ensure appropriate placement of purewick location.
Additional Manufacturer Narrative
The reported event was confirmed, cause unknown.Evaluation of the sample noted: a photo sample was returned of patient wound.Patient appeared to have blisters.As the device usage and the device, itself is not shown in the photo sample, the exact cause of the reaction is unable to be determined.The labeling is found to be adequate, as it states: "to avoid potential skin injury, never push or rub the product against the skin during placement or removal.Do not block airflow to the product (e.G., blocking the vent hole, bedpan, barrier creams).Do not insert the product into vagina, anus, or other body orifice.Stop 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.Do not use on users with frequent episodes of stool incontinence without a fecal management system in place.Do not use on users with skin irritation or breakdown at the site.Use with caution on users who had recent surgery of the external female anatomy.Do not use on users with moderate/heavy menstruation who cannot use a tampon." instructions also state: "reposition the product and check the user¿s skin at least every 2 hours or per hospital protocol." a dhr review is not required as the lot number is unknown.No actions can be taken at this time since a root cause was not identified.Corrections: d, 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.
Event or Problem Description
It was reported that the patient noted with multiple blisters intact and some burst causing open areas to bilateral lower buttocks and perineum area.It caused immobility, incontinence - stool, incontinence - urine, pressure to skin/tissue, skin moisture.Treatment provided such as pure wick removed, site care performed, moisture barrier cream applied.Per follow up actions performed on (b)(6) 2025 suspect pure wick injury, moisture barrier cream applied, and wound care consulted.Recommended to change and monitor skin under pure wick every shift and prn.Ensure appropriate placement of pure wick location.

• Brand Name: PUREWICK FLEX FEMALE CATHETER KIT
• Common Device Name: PUREWICK KIT
• 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: 23096543
• Report Number: 1018233-2025-08364
• Device Sequence Number: 9503908
• Product Code: NZU
• UDI-Device Identifier: 00801741226953
• UDI-Public: (01)00801741226953
• Combination Product (Y/N): N
• Initial Reporter State: LA
• 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,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/10/2025

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: Health Professional
• Device Catalogue Number: PWF030KX
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/18/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/18/2025
• Supplement Date Received by Manufacturer: 10/21/2025; 12/10/2025
• Initial Report FDA Received Date: 09/19/2025
• Supplement Report FDA Received Date: 10/22/2025; 12/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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 Age: 85 YR
• Patient Sex: Female