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

Catalog Number PW200

Device Problem Suction Failure (4039)

Patient Problem Urinary Tract Infection (2120)

Event Date 08/15/2023

Event Type  Injury  

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.H3 other text : the device was not returned.

Event Description

It was reported that the purewick urine collection system not working for the patient.It was stated that the patient was waking up wet.Per follow up via phone on (b)(6) 2023, the patient experienced an urinary tract infection because the unit was not suctioning, and was consistently wet.The patient was taken to the hospital for the urinary tract infection and was now in a rehabilitation facility and was no longer using the unit.

Event Description

It was reported that the purewick urine collection system not working for the patient.It was stated that the patient was waking up wet.Per follow up via phone on (b)(6)2023,the patient experienced an urinary tract infection because the unit was not suctioning, and was consistently wet.The patient was taken to the hospital for the urinary tract infection and was now in a rehabilitation facility and was no longer using the unit.

Manufacturer Narrative

The reported event was inconclusive because no sample was returned.A potential root cause for this failure could be "inadequate system design".It is unknown whether the device had met relevant specifications.The product was used for treatment purposes.It was unknown whether the product had caused the reported failure.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: ¿place the collection canister (c) in the purewick¿ urine collection system base and press down firmly on the lid making sure the lid is sealed.Attach the pump tubing (d) to the purewick¿ urine collection system connector port (f) and the connector port (e) on the collection canister lid.Attach the collector tubing (g) to the connector port (h) on the collection canister lid.Connect the other end of the collector tubing securely to a purewick¿ external catheter (i).[note the letters correlate to a diagram within the ifu].Caution: it is important that the port connections be connected correctly and securely for proper operation of the purewick¿ urine collection system." the device is on but is not suctioning properly: 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: xeeroy rada ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 17757255
• MDR Text Key: 323522300
• Report Number: 1018233-2023-06818
• 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: 09/25/2023

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?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: PW200
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/24/2023
• Initial Date FDA Received: 09/15/2023
• Supplement Dates Manufacturer Received: 09/25/2023
• Supplement Dates FDA Received: 09/27/2023
• 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