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

Catalog Number PWF030

Device Problems Fluid/Blood Leak (1250); Leak/Splash (1354)

Patient Problem Urinary Tract Infection (2120)

Event Type  Injury  

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 experienced leakage with the use of the wick and developed a urinary tract infection.Additional information has been requested but not yet received.

Manufacturer Narrative

The reported event was inconclusive as no sample was returned for evaluation.A potential root cause could be due to "inadequate material selection and/or wall thickness of tubing".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: " connect the other end of the 70¿ patient tubing securely to purewick¿ fec (h).Caution: it is important that the port connections be connected correctly for proper operation of the drydoc¿ vacuum station." (the letter (h) correlates to a diagram within the ifu.)" section a through f - the information provided by bd 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 bd.

Event Description

It was reported that the patient experienced leakage with the use of the wick and developed a urinary tract infection.

• Brand Name: PUREWICK FEMALE EXTERNAL.
• Type of Device: PUREWICK FEMALE EXTERNAL
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 9780675
• MDR Text Key: 183118169
• Report Number: 1018233-2020-01488
• Device Sequence Number: 1
• Product Code: NZU
• UDI-Device Identifier: 00801741143083
• UDI-Public: (01)00801741143083
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,distributor,other
• Type of Report: Initial,Followup
• Report Date: 04/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/03/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: PWF030
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/16/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other