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

Model Number PW100

Device Problem Biocompatibility (2886)

Patient Problems Scar Tissue (2060); Insufficient Information (4580)

Event Date 06/15/2021

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 caused the patient a medical issue that had to be corrected surgically, but the patient loved the system.Per follow up on (b)(6) 2021, patient had ovarian cancer and had to have surgery, also had scar tissue caused from using the purewick urine collection system.

Manufacturer Narrative

The reported event was inconclusive as no sample returned for evaluation.A potential root cause for this failure mode could be due to inadequate system design.It was unknown whether the product had caused the reported failure.It was unknown whether the device had met relevant specifications.The product was used for treatment purposes.The device was not returned for evaluation.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 pure wick¿ urine collection system base and press down firmly on the lid making sure the lid is sealed.Attach the pump tubing (d) to the pure wick¿ 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 pure wick¿ 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 pure wick¿ urine collection system.Discontinue use if an allergic reaction occurs.Not recommended for users who are experiencing skin irritation or skin breakdown in device contact areas." correction: b, e, f 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 caused the patient a medical issue which was corrected surgically but the patient loved the system.Per follow up on (b)(6) 2021 the patient had ovarian cancer underwent surgery and also had a scar tissue caused from using the purewick urine collection system.

• 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
• MDR Report Key: 12144181
• MDR Text Key: 260776855
• Report Number: 1018233-2021-04131
• 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: 09/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/09/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: PW100
• Device Catalogue Number: PW100
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/08/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention