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

Model Number PWFX30

Device Problems Biocompatibility (2886); Patient Device Interaction Problem (4001)

Patient Problems Skin Discoloration (2074); Discomfort (2330); Skin Inflammation/ Irritation (4545)

Event Date 02/17/2022

Event Type  Injury  

Event Description

It was reported that the purewick urine collection system had a bad suction, and the patient was getting skin irritation by using the purewick female external catheter.Patient needed help with trouble shooting.The patient has been using the purewick product for more than 90 days.Per follow up via phone on (b)(6) 2022, the purewick female external catheter caused discomfort, redness, and skin irritation.Patient did seek medical attention for the injury, stated that an ointment was prescribed and used.Also stated that the patient had not used the system since the skin irritation.

Manufacturer Narrative

The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.

Manufacturer Narrative

The reported event was inconclusive.No sample was returned for evaluation.A potential root cause could be due to "inadequate material selection - materials of construction are not biocompatible".It is unknown whether the device had met relevant specifications.The product was used for treatment purposes.It was unknown whether the product had caused the reported failure.The lot number was unknown; therefore, the device history record could not be reviewed.The instructions for use were found adequate and state the following: " discontinue use if an allergic reaction occurs." " replace the purewicktm female external catheter at least every 8-12 hours or if soiled with feces or blood.Always assess skin for compromise and perform perineal care prior to placement of a new purewicktm female external catheter." 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 Description

It was reported that the purewick urine collection system had a bad suction, and the patient was getting skin irritation by using the purewick female external catheter.Patient needed help with trouble shooting.The patient has been using the purewick product for more than 90 days.Per follow up via phone on 17feb2022, the purewick female external catheter caused discomfort, redness, and skin irritation.Patient did seek medical attention for the injury, stated that an ointment was prescribed and used.Also stated that the patient had not used the system since the skin irritation.

• Brand Name: PUREWICK FEMALE EXTERNAL CATHETER
• Type of Device: PUREWICK FEMALE EXTERNAL CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• Manufacturer (Section G): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• Manufacturer Contact: yonic anderson ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 13770057
• MDR Text Key: 287255177
• Report Number: 1018233-2022-01315
• Device Sequence Number: 1
• Product Code: NZU
• UDI-Device Identifier: 00801741189050
• UDI-Public: (01)00801741189050
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Consumer
• Reporter Occupation: Other Health Care Professional
• Type of Report: Followup
• Report Date: 05/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/15/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: PWFX30
• Device Catalogue Number: PWFX30
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/12/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Other
• Patient Sex: Female