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

Catalog Number PWKIT03

Device Problem Increase in Suction (1604)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 03/04/2024

Event Type  malfunction  

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.

Event Description

It was reported that purewick accessory replacement kit ordered in december.Where connector piece coming apart and it was suctioning to skin causing holes and collecting blood in canister.

Manufacturer Narrative

Upon further review, bd has determined that this mdr was reported in error as it was found to be a cascading failure of an event previously reported.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.

Event Description

It was reported that purewick accessory replacement kit ordered in december.Where connector piece coming apart and it was suctioning to skin causing holes and collecting blood in canister.

• 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: 18977855
• MDR Text Key: 338769648
• Report Number: 1018233-2024-01583
• 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: 05/04/2024

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 Catalogue Number: PWKIT03
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/04/2024
• Initial Date FDA Received: 03/26/2024
• Supplement Dates Manufacturer Received: 04/30/2024
• Supplement Dates FDA Received: 05/06/2024
• 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): Other
• Patient Sex: Female