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

Catalog Number PWF030

Device Problem Fluid/Blood Leak (1250)

Patient Problems Abrasion (1689); Pain (1994)

Event Date 01/05/2024

Event Type  Injury  

Manufacturer Narrative

The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.H11: section a through f - the information provided by bd represents all 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 bd.

Event Description

It was reported that the purewick female external catheter caused brush burns after a couple of days of use.Patient mentioned some administers of the device were more skilled, less skilled administers caused major leakage or mess (maybe also the above noted brush burns).Had to stop using the purewick and apply diaper cream to relieve the pain.

• 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: xeeroy rada ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 18581270
• MDR Text Key: 333742049
• Report Number: 1018233-2024-00264
• Device Sequence Number: 1
• Product Code: NZU
• UDI-Device Identifier: 00801741143083
• UDI-Public: (01)00801741143083
• 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
• Report Date: 01/10/2024

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?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: PWF030
• Device Lot Number: MYHU3876
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/06/2024
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/06/2024
• Initial Date FDA Received: 01/25/2024
• Was Device Evaluated by Manufacturer?: No
• 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