MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 PUREWICK URINE COLLECTION SYSTEM STND (NON-BATTERY); UNKNOWN PUREWICK SYSTEM

Catalog Number UNKNOWN

Device Problems Increase in Suction (1604); Device Contamination with Chemical or Other Material (2944)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

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 stated there were brown spots on the wicks and patient stated that the urologist told them the suction may be drying the patient's skin.

Event Description

It was reported that the patient stated there were brown spots on the wicks and the patient stated that the urologist told them the suction may be drying the patient's skin.Follow-up call performed on (b)(6) 2020, customer has a new unit and it was inconsistent with how well it collects the urine.When the patient disconnects the wick heard a swish like there was a pocket of air.

Manufacturer Narrative

The reported event was inconclusive, as no sample returned for evaluation.A potential root cause for this failure mode was unable to determine.It was unknown whether the device had met specifications.The product used for the treatment purposes.It was unknown whether the product had caused the reported failure.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 and the lot number for this device was unknown.Therefore, bard 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.H3 other text : the device was not returned.

• Brand Name: PUREWICK URINE COLLECTION SYSTEM STND (NON-BATTERY)
• Type of Device: UNKNOWN PUREWICK SYSTEM
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 10411261
• MDR Text Key: 203654279
• Report Number: 1018233-2020-05241
• 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,distributor,other
• Type of Report: Initial,Followup
• Report Date: 12/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/14/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/18/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1