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

Model Number PW200

Device Problem Misassembly by Users (3133)

Patient Problems Unspecified Infection (1930); Urinary Tract Infection (2120); Kidney Infection (4502)

Event Date 02/01/2022

Event Type  Injury  

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 urine collection system was not suctioning and the patient experienced leaks.Patient stated that they got really bad urinary tract infection and kidney infection from the purewick.Representative did troubleshooting and the purewick urine collection system was now suctioning.Patient had been using purewick products for less than 90 days.It was unknown what medical intervention was provided for urinary tract infection and kidney infection.

Event Description

It was reported that the purewick urine collection system was not suctioning and the patient experienced leaks.Patient stated that they got really bad urinary tract infection and kidney infection from the purewick.Representative did troubleshooting and the purewick urine collection system was now suctioning.Patient had been using purewick products for less than 90 days.It was unknown what medical intervention was provided for urinary tract infection and kidney infection.

Manufacturer Narrative

The reported event was confirmed use related as per reported event.The root cause for this failure was "user does not follow instructions".The lot number was unknown; therefore, the device history record could not be reviewed.The instructions for use were found adequate and state the following: "1.Ensure tubing connections are connected properly.2.Check collector tubing for blockage or flow restriction such as pinched or kinked tubing.3.Ensure overflow stop valve in collection canister lid is open.The valve floats to the top when the collection canister is full.The stop valve may close if the lid or canister is tipped sideways or upside down.Disconnect tubing and gently shake the lid to reset the valve down to the open position.4.Ensure collection canister is sealed with the lid tightly closed.5.Verify suction by disconnecting purewick¿ external catheter from the collector tubing and placing the end of the collector tubing into a cup of water.If water easily flows into the collection canister replace the purewick¿ external catheter".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.

• 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: yonic anderson ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 13596259
• MDR Text Key: 286175133
• Report Number: 1018233-2022-00866
• Device Sequence Number: 1
• Product Code: NZU
• UDI-Device Identifier: 00801741185359
• UDI-Public: (01)00801741185359
• 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: 04/26/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: PW200
• Device Catalogue Number: PW200
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/01/2022
• Initial Date FDA Received: 02/24/2022
• Supplement Dates Manufacturer Received: 04/26/2022
• Supplement Dates FDA Received: 05/19/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Sex: Female