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

Catalog Number UNKNOWN

Device Problem Biocompatibility (2886)

Patient Problem Urinary Tract Infection (2120)

Event Date 12/04/2020

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 has stopped using the purewick urine collection system due to experiencing a very bad urinary tract infection.The representative apologized and advised that the system will usually lower the risk of getting the urinary tract infections.Per follow-up made on (b)(6) 2020, the customer stopped using the device for about a week due to the doctor's order after experiencing a urinary tract infection.The patient was unsure that the issue was related to the device.Also, indicated that the customer was about to start using the device again.

Event Description

It was reported that the patient has stopped using the purewick urine collection system due to experiencing a very bad urinary tract infection.The representative apologized and advised that the system will usually lower the risk of getting the urinary tract infections.Per follow up made on 16dec2020 the customer stopped using the device for about a week due to the doctors order after experiencing a urinary tract infection.The patient was unsure that the issue was related to the device.Also indicated that the customer was about to start using the device again.

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 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 inspection error which leads to unaware effect or the supplier issue which provide the poor shell this leads to skin irritation or dermatitis or minor blistering appearance or skin tears or skin lesions.The device was not returned for evaluation.The lot number was unknown therefore the device history record could not be reviewed.The product catalog number for this device was unknown.Therefore bd was unable to determine the associated labeling to review.H11: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.

• Brand Name: UNKNOWN PUREWICK FEMALE EXTERNAL CATHETER
• Type of Device: UNKNOWN PUREWICK FEMALE EXTERNAL CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• MDR Report Key: 11085639
• MDR Text Key: 224252087
• Report Number: 1018233-2020-22077
• Device Sequence Number: 1
• Product Code: NZU
• 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,other
• Type of Report: Initial,Followup
• Report Date: 03/03/2021

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?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/04/2020
• Initial Date FDA Received: 12/29/2020
• Supplement Dates Manufacturer Received: 03/03/2021
• Supplement Dates FDA Received: 03/25/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other