MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 UNKNOWN PUREWICK DISPOSABLE; UNKNOWN PUREWICK CATHETER

Model Number PW100

Device Problem Biocompatibility (2886)

Patient Problems Unspecified Infection (1930); Kidney Infection (4502)

Event Date 06/21/2021

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 had a kidney infection, so the patient was not using the purewick urine collection system.The patient did not say the infection was from the purewick system.It was unknown what medical intervention was provided for kidney infection.

Manufacturer Narrative

The reported event was inconclusive as no sample returned for evaluation.It was unknown whether the device had met relevant specifications.The product was used for urological care.It was unknown whether the product had caused the reported failure.A potential root cause for this failure mode could be due to the material surface was rough or abrasive or uncomfortable.The device was not returned for evaluation.The lot number was unknown therefore the device history record could not be reviewed.The labeling review was unable to review due to the unknown product code.Although the product family was unknown the (purewick) ifus were found to be adequate based on past reviews.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.H3 other text : the device was not returned.

Event Description

It was reported that the patient had a kidney infection and was not using the purewick urine collection system.The patient did not say the infection was from the purewick system.It is unknown what medical intervention was provided for the kidney infection.Per follow up call performed on (b)(6) 2021 it was stated by the patient that they had many infections and was instructed not to use the machine and did not use the device for a long time hence the patient now had a catheter.Also stated that they only used the purewick 3 weeks before the infections began but did not state definitely the infections were caused by the purewick.

• Brand Name: UNKNOWN PUREWICK DISPOSABLE
• Type of Device: UNKNOWN PUREWICK CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• MDR Report Key: 12170919
• MDR Text Key: 261666720
• Report Number: 1018233-2021-04219
• Device Sequence Number: 1
• Product Code: NZU
• UDI-Device Identifier: 00801741185342
• UDI-Public: (01)00801741185342
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Source Type: consumer,other
• Type of Report: Initial,Followup
• Report Date: 08/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/14/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: PW100
• Device Catalogue Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/28/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other