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

Model Number PWFX30

Device Problems Positioning Failure (1158); Malposition of Device (2616)

Patient Problem Rash (2033)

Event Date 01/13/2022

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 patient used purewick female external catheter in the hospital and stated some nurses placed it inside the vagina and some outside of the vagina hence the patient got a rash from it.Representative informed the patient that the purewick female external catheters are external and should not be placed inside of the vagina and stated that might be the reason why the patient got a rash.Representative advised that the patient could place the purewick female external catheter themselves if patient purchased the at home version.No medical intervention was reported.

Manufacturer Narrative

The reported event was confirmed as use related.No sample was returned for evaluation.A potential root cause for this failure could be "user unaware of correct use of device, places device incorrectly".It was unknown whether the device had met relevant specifications.The product was used for treatment purposes.The failure was caused by the misuse of the product.A dhr review is not required because the investigation was confirmed as use related.The instructions for use were found adequate and state the following: "indication for use: the purewicktm female external catheter is intended for non-invasive urine output management in female patients." the ifu also states "¿ 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.¿ 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 Description

It was reported that the patient used purewick female external catheter in the hospital and stated some nurses placed it inside the vagina and some outside of the vagina hence the patient got a rash from it.Representative informed the patient that the purewick female external catheters are external and should not be placed inside of the vagina and stated that might be the reason why the patient got a rash.Representative advised that the patient could place the purewick female external catheter themselves if patient purchased the at home version.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: yonic anderson ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 13451252
• MDR Text Key: 286525362
• Report Number: 1018233-2022-00392
• 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: Initial,Followup
• Report Date: 03/30/2022

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: Lay User/Patient
• Device Model Number: PWFX30
• Device Catalogue Number: PWFX30
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/13/2022
• Initial Date FDA Received: 02/04/2022
• Supplement Dates Manufacturer Received: 03/30/2022
• Supplement Dates FDA Received: 04/26/2022
• 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