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

Model Number PW100

Device Problem Increase in Suction (1604)

Patient Problems Bruise/Contusion (1754); Hematoma (1884)

Event Date 09/17/2020

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 purewick caused a bruise to the patient¿s pubic area, just above the labial separation.During a follow-up phone call with liberator medical supply on (b)(6) 2020, the complainant reported that her mother, the user of the device, developed the bruise after one night of use.The complainant also reported the patient had expired.Additional information was received via phone on (b)(6) 2020 from the complainant.The patient was an (b)(6)-year-old female receiving care at home after a hip fracture on (b)(6) 2020.The patient had used the purewick device during previous hospitalizations during the month of april, and wanted to use it at home.The complainant stated that the visiting nurse advised her the suction may be too strong as the patient was very frail and only weighed ninety-three lbs.This event occurred in april and the device was not used again.The patient expired while receiving hospice care on (b)(6) 2020.The patient¿s daughter reported the death was expected, and not related to the device.The daughter stated the cause of death was congestive heart failure.

Manufacturer Narrative

The reported event was inconclusive.It was unknown whether the device had met specifications.The product was used for treatment purposes.It was unknown whether the product had caused the reported failure.No sample was returned for evaluation.A potential root cause for this failure could be due to "inadequate component (pump and relief valve) selection".The device was not returned for evaluation.The lot number is unknown; therefore, the device history record could not be reviewed.A labeling review was not performed as high suction from the pw100 would not likely be caused by the user.The device was not returned.

Event Description

It was reported that the purewick caused a bruise to the patient¿s pubic area, just above the labial separation.During a follow-up phone call with liberator medical supply on (b)(6) 2020, the complainant reported that her mother, the user of the device, developed the bruise after one night of use.The complainant also reported the patient had expired.Additional information was received via phone on 22sep2020 from the complainant.The patient was an 83-year-old female receiving care at home after a hip fracture on (b)(6) 2020.The patient had used the purewick device during previous hospitalizations during the month of april and wanted to use it at home.The complainant stated that the visiting nurse advised her the suction may be too strong as the patient was very frail and only weighed ninety-three lbs.This event occurred in april and the device was not used again.The patient expired while receiving hospice care on 24may2020.The patient¿s daughter reported the death was expected and not related to the device.The daughter stated the cause of death was congestive heart failure.

• Brand Name: PUREWICK URINE COLLECTION SYSTEM STANDARD
• Type of Device: PUREWICK URINE COLLECTION SYSTEM
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• MDR Report Key: 10658243
• MDR Text Key: 210699672
• Report Number: 1018233-2020-20044
• 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
• Report Date: 04/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/09/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: PW100
• Device Catalogue Number: PW100
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/24/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 83 YR
• Patient Weight: 42