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

Model Number PW100

Device Problems Increase in Suction (1604); Suction Problem (2170)

Patient Problems Hemorrhage/Bleeding (1888); Patient Problem/Medical Problem (2688)

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 purewick urine collection system had the suction issues caused bleeding and the patient had only used the wicks 3 times and when they remove it, there was a blood.Advised patient to seek medical attention and discontinued use of product.No medical intervention was reported.

Event Description

It was reported that purewick urine collection system had the suction issues which caused bleeding and the patient had only used the wicks 3 times and when they removed it, there was a blood.Patient was advised to seek medical attention and discontinue use of product.No medical intervention was reported.

Manufacturer Narrative

The reported event was inconclusive as no sample was returned for evaluation.A potential root cause could be due to an "inadequate component (pump and relief valve) selection".The device history record was reviewed and found nothing that could have caused or contributed to the reported event.Labeling review was not performed as high suction from the pw100 would not likely be caused by the user.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
• Type of Device: PUREWICK URINE COLLECTION SYSTEM
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 10477788
• MDR Text Key: 206307505
• Report Number: 1018233-2020-05596
• 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,distributor,other
• Type of Report: Initial,Followup
• Report Date: 01/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/27/2021
• Device Model Number: PW100
• Device Catalogue Number: PW100
• Device Lot Number: BMENPX94
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/10/2020
• Initial Date FDA Received: 09/01/2020
• Supplement Dates Manufacturer Received: 01/04/2021
• Supplement Dates FDA Received: 01/21/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1