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

Model Number PWKIT03

Device Problems Misassembly by Users (3133); Device Handling Problem (3265)

Patient Problems Calcium Deposits/Calcification (1758); Urinary Tract Infection (2120)

Event Date 02/09/2022

Event Type  Injury  

Event Description

It was reported that the patient asked about canister replacement.The patient stated that they were taking a sample for urinary tract infection and calcium buildup.It was also stated that the patient had not made a urinary tract infection allegation against the purewick.It was noted that the replacement purewick accessory kit was shipped on 29nov2021 and the patient had been using purewick products for more than 90 days.It was unknown if the device contributed to the urinary tract infection at this time, and the medical intervention was unknown.

Manufacturer Narrative

The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.

Manufacturer Narrative

The reported event was confirmed use related as the user did not replace the accessories after 60 days.It was unknown whether the device had met specifications.The product was used for treatment purposes.The failure was caused by the misuse of the product.The root cause of this failure is "user does not follow instructions".A dhr review is not required as the event is use related.The instructions for use were found adequate and state the following: "replace the canister and tubing for each patient per facility protocol or at least every 60 days, whichever is sooner.If you notice any of the following, replace immediately: canister or tubing has residual urine build-up.Canister or tubing appear cloudy.Canister or tubing appear discolored.Canister becomes cracked.Tubing becomes torn.Purewick¿ external catheter no longer securely connects to collector tubing.Failure to clean and/or replace accessories may affect the performance of the system.The useful life of the collection canister and tubing is 60 days." h11: section a through f - the information provided by bd 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 bd.H3 other text: the device was not returned.

Event Description

It was reported that the patient asked about canister replacement.The patient stated that they were taking a sample for urinary tract infection and calcium buildup.It was also stated that the patient had not made a urinary tract infection allegation against the purewick.It was noted that the replacement purewick accessory kit was shipped on 29nov2021 and the patient had been using purewick products for more than 90 days.It was unknown if the device contributed to the urinary tract infection at this time, and the medical intervention was unknown.

• 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: 13691258
• MDR Text Key: 286741092
• Report Number: 1018233-2022-01097
• 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: 05/06/2022

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: PWKIT03
• Device Catalogue Number: PWKIT03
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/09/2022
• Initial Date FDA Received: 03/08/2022
• Supplement Dates Manufacturer Received: 05/06/2022
• Supplement Dates FDA Received: 05/18/2022
• 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