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

Model Number PWF030K

Device Problem Increase in Suction (1604)

Patient Problem Skin Tears (2516)

Event Date 06/17/2022

Event Type  malfunction  

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 Description

It was reported that the user facility had an unfortunate event with purewick female external catheter where the suction was turned up too high in the purewick urine collection system and the patient developed a skin tear.Customer stated that as per their nursing procedure and education material, the instructions were to start at 40mmhg.It was also mentioned that they missed to test the system prior to placement, check connections and for kinks in system as mentioned in the instructions.No medical intervention was reported.

Manufacturer Narrative

The reported event was inconclusive.No sample was returned for evaluation.A potential root cause for this failure could be due to "inspector/inspection error - unaware of defect".It was unknown whether the device had met specifications.The product was used for treatment purposes.It was unknown whether the product had caused the reported failure.The device was not returned for evaluation.The lot number is unknown; therefore, the device history record could not be reviewed.A labeling review is not required because labeling could not have prevented the reported issue.The device was not returned.

Event Description

It was reported that the user facility had an unfortunate event with purewick female external catheter where the suction was turned up too high in the purewick urine collection system and the patient developed a skin tear.Customer stated that as per their nursing procedure and education material, the instructions were to start at 40mmhg.It was also mentioned that they missed testing the system before placement, to check connections and for kinks in the system, as mentioned in the instructions.No medical intervention was reported.

• 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: juan velez ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 14934493
• MDR Text Key: 302122978
• Report Number: 1018233-2022-05212
• Device Sequence Number: 1
• Product Code: NZU
• UDI-Device Identifier: 00801741183614
• UDI-Public: (01)00801741183614
• 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,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/07/2022

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
• Device Operator: Health Professional
• Device Model Number: PWF030K
• Device Catalogue Number: PWF030K
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/17/2022
• Initial Date FDA Received: 07/06/2022
• Supplement Dates Manufacturer Received: 10/07/2022
• Supplement Dates FDA Received: 10/11/2022
• 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): Other
• Patient Sex: Female