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

Model Number	PWF030
Medical Device Problem Code	Increase in Suction (1604)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	10/28/2021
Type of Reportable Event	Malfunction
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 patient experienced bleeding at the labia area on (b)(6) 2021 at intensive care unit and experienced bruising at the labia area on (b)(6) 2021.Reviewed with customer and noted that purewick suction was not occurring on the labia but was on the distal end of purewick.Also reviewed the suction, skin checks q2 and changing purewick every shift or as needed.Also, customer asked if purewick needed to be removed when patients were using a bed pain.Also, customer thought that if the suction was high it will cause bleeding in the labia.No medical intervention was reported.
Additional Manufacturer Narrative
The reported event is inconclusive as no sample was returned for evaluation.A potential root cause could be due to "dimensions not specified correctly".The device was not returned for evaluation.The lot number is unknown; therefore, the device history record could not be reviewed.The instructions for use were found adequate and state the following: "setup: 1.Connect the canister to wall suction and set to a minimum of 40mmhg continuous suction.Always use the minimum amount of suction necessary.If using the drydoctm vacuum station, connect the canister to the unit and turn the unit on.Please consult the drydoctm vacuum station user guide for further information.2.Using standard suction tubing, connect the purewicktm female external catheter to the collection canister." the device was not returned.
Event or Problem Description
It was reported that the patient experienced bleeding at the labia area on 28oct2021 while in the intensive care unit.Another incident occurred on 02nov2021 in the tele unit, where the patient experienced bruising at the labia area.Bd sr.Specialist reviewed purewick with customer that suction was not occurring on the labia but was on the distal end of purewick.They also reviewed suction, skin checks every 2 hours, and changing the purewick every shift or prn.Complainant also asked if purewick needed to be removed when patients were using a bed pan.Complainant thought the suction occurred on the labia, causing bleeding if the suction was high.No medical intervention was reported.Per follow up via phone on 30nov2021, the complainant reported the patient died from issues unrelated to the purewick device, as the patient was in hospice care.

• 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: 12860072
• Report Number: 1018233-2021-07476
• Device Sequence Number: 14560421
• Product Code: NZU
• UDI-Device Identifier: 00801741143083
• UDI-Public: (01)00801741143083
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/04/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: PWF030
• Device Catalogue Number: PWF030
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/04/2021
• Supplement Date Received by Manufacturer: 02/04/2022
• Initial Report FDA Received Date: 11/23/2021
• Supplement Report FDA Received Date: 03/01/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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