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

Model Number	PWF030K
Medical Device Problem Code	Biocompatibility (2886)
Health Effect - Clinical Code	Pressure Sore/Ulcer (2326)
Date of Event	08/25/2021
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.The device was not returned.
Event or Problem Description
It was reported that the patient experienced device related pressure injury on the mucous membrane which was unstageable by using the purewick female external catheter.And the purewick female external catheter was removed and zgaurd was applied on the affected area.
Additional Manufacturer Narrative
The reported event is inconclusive as no sample was returned for evaluation.A potential root cause could be due to "inadequate material selection - materials of construction are not biocompatible".It was unknown whether the device had met specifications.The product was used for treatment but it was unknown whether the product had caused the reported failure.A review of the device history record did not show any problems or conditions that would have contributed to the reported issue.Therefore, no additional action is required at this time.The device was not returned for evaluation.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.The instructions for use were found adequate and state the following: "warnings: ¿ to avoid potential skin injury, never push or pull the purewicktm female external catheter against the skin during placement or removal.¿ never insert the purewicktm female external catheter into vagina, anal canal, or other body cavities.¿ discontinue use if an allergic reaction occurs.Removal: to remove the purewicktm female external catheter, fully separate the legs, gluteus, and labia.To avoid potential skin injury upon removal, gently pull the purewicktm female external catheter directly outward.Ensure suction is maintained while removing the purewicktm female external catheter.After use, this product may be a potential biohazard.Dispose of in accordance with applicable local, state and federal laws and regulations.Recommendations: ¿ perform each step with clean technique.In the home setting, wash hands thoroughly before device placement.¿ assess device placement and patient¿s skin at least every 2 hours.¿ replace the purewicktm female external catheter every 8-12 hours or when soiled with feces or blood.¿ change suction tubing per hospital protocol or at least every thirty (30) days.Not recommended for patients who are: experiencing skin irritation or breakdown at the site." h11: section a through f - the information provided by bard represents all of 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 bard.H3 other text : the device was not returned.
Event or Problem Description
It was reported that the patient experienced device related pressure injury on the mucous membrane which was unstageable by using the purewick female external catheter.And the purewick female external catheter was removed and zgaurd was applied on the affected area.

• Brand Name: PUREWICK FEMALE EXTERNAL CATHETER
• Common Device Name: 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: 12750610
• Report Number: 1018233-2021-06959
• Device Sequence Number: 20063813
• Product Code: NZU
• UDI-Device Identifier: 00801741183614
• UDI-Public: (01)00801741183614
• Combination Product (Y/N): N
• Initial Reporter State: ME
• 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
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/10/2022

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 Expiration Date: 03/28/2023
• Device Model Number: PWF030K
• Device Catalogue Number: PWF030K
• Device Lot Number: MYFQ0069
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/08/2021
• Supplement Date Received by Manufacturer: 01/10/2022
• Initial Report FDA Received Date: 11/04/2021
• Supplement Report FDA Received Date: 01/26/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/12/2021
• 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: Required Intervention
• Patient Age: 81 YR
• Patient Sex: Female
• Patient Weight: 72 KG