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

Catalog Number	PWF030
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Urinary Tract Infection (2120)
Date of Event	07/21/2025
Type of Reportable Event	Serious Injury
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 labeling is found to be adequate.The baw is attached on the investigation overview element.A dhr could not be performed since no lot number was provided.No additional actions can be taken at this time.Corrections: a, d 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 was hospitalized for several days and confined to bed.During that time, the hospital provided them with a purewick external catheter while patient initially appreciated the convenience it seemed to offer, but began noticing a troubling change: a constant, urgent need to urinateâ¿¿something they had not experienced prior to my hospitalization.Upon discharge, the situation worsened considerably and was unable to control the urge to urinate and began experiencing frequent accidents.The urgency was so severe and unpredictable that patient had to wear double protective undergarments and, for a time, could not leave home.Eventually, patient was diagnosed with a urinary tract infection, which my medical team believes may have been caused by the use of the purewick product.It was unknown what medical intervention was provided for urinary tract infection.
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 patient was hospitalized for several days and confined to bed.During that time, the hospital provided them with a purewick external catheter while patient initially appreciated the convenience it seemed to offer, but began noticing a troubling change: a constant, urgent need to urinate something they had not experienced prior to my hospitalization.Upon discharge, the situation worsened considerably and was unable to control the urge to urinate and began experiencing frequent accidents.The urgency was so severe and unpredictable that patient had to wear double protective undergarments and, for a time, could not leave home.Eventually, patient was diagnosed with a urinary tract infection, which my medical team believes may have been caused by the use of the purewick product.It was unknown what medical intervention was provided for urinary tract infection.

• Brand Name: PUREWICK FEMALE EXTERNAL CATHETER
• Common Device Name: FEMALE EXTERNAL 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: 22587332
• Report Number: 1018233-2025-06090
• Device Sequence Number: 21205509
• Product Code: NZU
• UDI-Device Identifier: 00801741143083
• UDI-Public: (01)00801741143083
• Combination Product (Y/N): N
• Initial Reporter State: KY
• 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): 07/29/2025

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: PWF030
• 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: 07/21/2025
• Supplement Date Received by Manufacturer: 07/28/2025
• Initial Report FDA Received Date: 07/24/2025
• Supplement Report FDA Received Date: 07/29/2025
• 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