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

Model Number PW100

Device Problems No Apparent Adverse Event (3189); Missing Information (4053)

Patient Problems Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/15/2021

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 patient's caregiver stated there was a step missing in the instruction.It was noted that the purewick product shipped on 13aug2021.

Manufacturer Narrative

The reported event was inconclusive.No sample was returned for evaluation.A potential root cause for this failure could be due to "missing instructions; vendor/printer error ".It was unknown whether the device had met specifications.The device was not returned for evaluation.The lot number is unknown; therefore, the device history record could not be reviewed.The instructions for use were found adequate and state the following: "please read all operating instructions and warnings before the first use of this product.No special skills or additional training is required".H11: section a through f - the information provided by bard represents all of 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 bard.H3 other text : the device was not returned.

Event Description

It was reported that the patient's caregiver stated there was a step missing in the instruction.It was noted that the purewick product shipped on (b)(6) 2021.

Event Description

It was reported that the patient's caregiver stated there was a step missing in the instruction.It was noted that the purewick product shipped on (b)(6) 2021.Per customer via return call on (b)(6) 2021, customer had no complaint but felt like the instructions in the quick reference guide did not provide enough information.Specifically, when to turn on the machine suction or off the machine suction when putting the purewick female external catheter in place or removing the purewick catheter after use.The patient also stated that the short tube of the purewick replacement kit that connected the canister to the lid developed condensation during the cleaning process.Patient enquired about where the condensation would go when it moves from the tube into the base and if it sat in the bottom and resulted in mildew.Customer also suggested that there should be a way for the urine going into the canister to diffuse the water so that it would not make so much noise going into the canister.Customer suggested a tab of some sort for the water to fan across and more gentle flow into the canister.

Manufacturer Narrative

Per additional information received, bd has determined that this mdr event is not reportable.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: 12446246
• MDR Text Key: 270515364
• Report Number: 1018233-2021-05518
• Device Sequence Number: 1
• Product Code: NZU
• UDI-Device Identifier: 00801741185342
• UDI-Public: (01)00801741185342
• 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,Followup
• Report Date: 01/06/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• 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
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/15/2021
• Initial Date FDA Received: 09/09/2021
• Supplement Dates Manufacturer Received: 10/15/2021; 12/14/2021
• Supplement Dates FDA Received: 11/08/2021; 01/06/2022
• 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