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

Device Problem Suction Failure (4039)

Patient Problem Skin Inflammation/ Irritation (4545)

Event Date 10/27/2023

Event Type  Injury  

Event Description

It was reported that purewick urine collection system had weak suction.Per follow up via phone on 05oct2023, it was reported that the initial purewick urine collection system had no power at all.A replacement device was sent and now the replacement has no suction.Caretaker has performed troubleshooting and the water test failed and stated that the wicks and the patient were saturated with urine.All attachments are plugged in securely and purewick urine collection system was sitting on the floor and new wicks were ordered.When they tried the new wicks, it did not change the suction and issue has not been resolved.Per follow up via phone on (b)(6) 2023, it was reported that purewick urine collection system has completely stopped working.Caregiver stated that purewick urine collection system was defective and stayed on hold for 45 minutes with no response.Customer has sores from sitting in urine due to the device not functioning properly and was prescribed an oral antibiotic to treat the sores.Customer was unhappy that the issue remains unsolved and needs the defective device to be replaced as soon as possible.Per follow up via phone on 09nov2023, it was reported that the customer received a replacement and will return the old unit.The customer did seek medical intervention for the sores and was prescribed antibiotics.

Manufacturer Narrative

The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.H11: section a through f - the information provided by bd represents all 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.

Manufacturer Narrative

Upon further review, bd has determined that this mdr was reported in error as it was found to be a duplicate of an event previously reported.H11: section a through f - the information provided by bd represents all 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.

Event Description

It was reported that purewick urine collection system had weak suction.Per follow up via phone on 05oct2023, it was reported that the initial purewick urine collection system had no power at all.A replacement device was sent and now the replacement has no suction.Caretaker has performed troubleshooting and the water test failed and stated that the wicks and the patient were saturated with urine.All attachments are plugged in securely and purewick urine collection system was sitting on the floor and new wicks were ordered.When they tried the new wicks, it did not change the suction and issue has not been resolved.Per follow up via phone on 27oct2023, it was reported that purewick urine collection system has completely stopped working.Caregiver stated that purewick urine collection system was defective and stayed on hold for 45 minutes with no response.Customer has sores from sitting in urine due to the device not functioning properly and was prescribed an oral antibiotic to treat the sores.Customer was unhappy that the issue remains unsolved and needs the defective device to be replaced as soon as possible.Per follow up via phone on 09nov2023, it was reported that the customer received a replacement and will return the old unit.The customer did seek medical intervention for the sores and was prescribed antibiotics.

• 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 30014
• Manufacturer (Section G): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• Manufacturer Contact: xeeroy rada ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 18158911
• MDR Text Key: 328386044
• Report Number: 1018233-2023-08220
• Device Sequence Number: 1
• Product Code: NZU
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Consumer
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 12/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/17/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/01/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Sex: Female