MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 PUREWICK ACCESSORIES REPLACEMENT KIT

Model Number PWKIT03

Device Problems Fracture (1260); Inadequate or Insufficient Training (1643)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/22/2022

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 purewick accessory kit had cracks and was never told it needed to be replaced.It was noted that the patient had been using the purewick products for more than 90 days.It was also noted that the purewick accessory kit was originally shipped with the purewick urine collection system on 11jun2021.

Manufacturer Narrative

Per additional information received, it has been determined that this mdr event is not reportable.The device was not returned.

Event Description

It was reported that the purewick accessory kit had cracks and was never told it needed to be replaced.It was noted that the patient had been using the purewick products for more than 90 days.It was also noted that the purewick accessory kit was originally shipped with the purewick urine collection system on 11jun2021.Per additional information received via follow-up on 18may2022, it was stated that the canister was cracked and the purewick urine collection system was affected by the cracked canister.Customer taped it and kept using it.

• Brand Name: PUREWICK ACCESSORIES REPLACEMENT KIT
• Type of Device: PUREWICK ACCESSORIES REPLACEMENT KIT
• 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: 14434414
• MDR Text Key: 292050652
• Report Number: 1018233-2022-03873
• Device Sequence Number: 1
• Product Code: NZU
• UDI-Device Identifier: 00801741185380
• UDI-Public: (01)00801741185380
• 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: 06/10/2022

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: PWKIT03
• Device Catalogue Number: PWKIT03
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/22/2022
• Initial Date FDA Received: 05/19/2022
• Supplement Dates Manufacturer Received: 05/18/2022
• Supplement Dates FDA Received: 06/10/2022
• 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