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

Model Number PW100

Device Problem Biocompatibility (2886)

Patient Problems Abscess (1690); Urinary Tract Infection (2120)

Event Date 01/19/2021

Event Type  Injury  

Manufacturer Narrative

The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.

Event Description

It was reported that the patient may be experiencing urinary tract infection due to the purewick urine collection system.Per troubleshooting advised patient for proper use time frame and cleaning and patient did mention did that one of the care taker does not wear glove when changing the patient.It was unknown what medical intervention was provided for urinary tract 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 product catalog number for this device was unknown.Therefore bd was unable to determine the associated labeling to review.Correction: d, e, f 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.The device was not returned.

Event Description

It was reported that the patient might be experiencing a urinary tract infection due to the purewick urine collection system.Per troubleshooting it was advised to the patient regarding the proper use time frame and cleaning.The patient mentioned that the caretaker did not wear a glove when changing the patient.It is unknown what medical intervention was provided for the urinary tract infection.Per additional information received via email on 16apr2021 it was stated that the alleged complaint was against the purewick catheter but not the purewick urine collection system and noted as unknown purewick female external catheter.

Manufacturer Narrative

The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.Correction : d.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 the patient might be experiencing urinary tract infection due to the purewick urine collection system.Per troubleshooting advised patient for proper use time frame and cleaning and patient did mention did that one of the care taker does not wear glove when changing the patient.It was unknown what medical intervention was provided for urinary tract infection.Per additional information received on 16apr2021, the alleged complaint was against the purewick catheter and not the purewick urine collection system.

• Brand Name: UNKNOWN PUREWICK DISPOSABLE
• 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: 11321877
• MDR Text Key: 231621493
• Report Number: 1018233-2021-00475
• 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): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Type of Report: Initial,Followup,Followup
• Report Date: 05/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/12/2021
• 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: 05/27/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other