MAUDE Adverse Event Report: C.R. Bard Inc. (Covington) -1018233 PureWick Flex Female External Catheter

Catalog Number	PWFXH30
Medical Device Problem Code	Disconnection (1171)
Health Effect - Clinical Code	Blister (4537)
Date of Event	08/10/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that they circling back on another injury related to the purewick female external catheter disconnecting from the tubing, which resulted in a blister on the patient abdomen.When they discussed that, they emphasized the importance of connecting the device to suction before applying that to the patient.That appeared that staff would benefit from reeducation on the proper application process.They wanted to share that information and pass that along for continued education planning.Per additional information received via email on 25aug2026 stated that there was a third incident that was reported last week.No physical samples available they did not had lot and serial number of the purewick flex or suction tubing age (b)(6), white, female, 125 lbs (weight), 5 ' (height) i cannot provide birthday or name patient sustained a blood blister, area was treated with wound cleanser and a bordered foam dressing by nursing, she was discharged and not seen by wound care team.
Event or Problem Description
It was reported that they circling back on another injury related to the purewick female external catheter disconnecting from the tubing, which resulted in a blister on the patient's abdomen.When they discussed that, they emphasized the importance of connecting the device to suction before applying that to the patient.That appeared that staff would benefit from reeducation on the proper application process.They wanted to share that information and pass that along for continued education planning.Per additional information received via email on 25-aug-2026 stated that there was a third incident that was reported last week.No physical samples available.They did not have a lot or serial number of the purewick flex or suction tubing.Patient details are age 89, white, female, 125 lbs, 5 ft tall.I cannot provide birthday or name of patient.The patient sustained a blood blister and the area was treated with wound cleanser and a bordered foam dressing by nursing.She was discharged and not seen by wound care team.
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.
Additional Manufacturer Narrative
Our team conducted a thorough review of the reported event to ensure the ongoing safety and performance of the product.Via photo sample analysis, the investigation did not identify any product performance issues that would be prospective to lead to the reported event, as no physical sample was returned.It is unknown if the product met relevant specifications.The product was used for treatment purposes.It is unknown if the product caused the reported failure.Visual evaluation of the returned photo sample appears to show a skin reaction/bruise.No product was seen in the photo, and the investigation was unable to determine if a disconnection occurred without a physical sample.Product labeling, was reviewed for this investigation, and the reported event is included within the labeling as it states: to avoid potential skin injury, never push or pull the purewicktm female external catheter against the skin during placement or removal.Precautions use with caution on users who are agitated, combative or uncooperative and might remove the product.As the lot number is unknown, a dhr is not required.Based on the results of the investigation, no additional action is required at this time.Corrections: d, g 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 Flex 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 ; +1(770)784-6100
• MDR Report Key: 50499332
• Report Number: 1018233-2026-05622
• Device Sequence Number: 18499669
• Product Code: NZU
• UDI-Device Identifier: 00801741226984
• UDI-Public: (01)00801741226984
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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
• Report Date (Section B): 08/28/2026

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: PWFXH30
• 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: 08/25/2026
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/28/2026
• Supplement Report FDA Received Date: 09/03/2026
• 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 Age: 89 YR
• Patient Sex: Female
• Patient Weight: 125 LB
• Patient Race: White