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

Model Number PWFX30

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Urinary Tract Infection (2120)

Event Date 12/01/2022

Event Type  Injury  

Event Description

It was reported that two purewick female external catheters were open and wet.Patient had been using the purewick product for more than 90 days.As per follow up via phone on (b)(6) 2022, it was reported that the customer received two purewick female external catheters that were wet and opened upon receipt.Customer also stated that they had experienced urinary tract infections the last two months and received bactrim from their doctor to combat the infection and they used the system contiguously for at least 12 hours at a time.

Manufacturer Narrative

The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.The device was not returned.

Manufacturer Narrative

The reported event was inconclusive because no sample was returned.A potential root cause for this failure could be "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 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: "warnings: discontinue use if an allergic reaction occurs.After use, this product may be a potential biohazard.Dispose of in accordance with applicable local, state and federal laws and regulations.Precautions: not recommended for patients who are: agitated, combative, or uncooperative and might remove the purewicktm female xternal catheter.Experiencing skin irritation or breakdown at the site.Always assess skin for compromise and perform perineal care prior to placement of a new purewicktm female external catheter.Recommendations: 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." 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 two purewick female external catheters were open and wet.Patient had been using the purewick product for more than 90 days.As per follow up via phone on 01dec2022, it was reported that the customer received two purewick female external catheters that were wet and opened upon receipt.Customer also stated that they had experienced urinary tract infections the last two months and received bactrim from their doctor to combat the infection and they used the system contiguously for at least 12 hours at a time.

• Brand Name: PUREWICK FEMALE EXTERNAL CATHETER LF HC
• 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: xeeroy rada ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 16005056
• MDR Text Key: 305712413
• Report Number: 1018233-2022-09655
• 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: 01/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2022
• 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: 01/20/2023
• 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
• Patient Sex: Female