MAUDE Adverse Event Report: BARD ACCESS SYSTEMS, INC. POWERPICC; CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Model Number CK000187B

Device Problems Product Quality Problem (1506); Component Missing (2306)

Patient Problem Insufficient Information (4580)

Event Date 01/29/2022

Event Type  malfunction  

Event Description

Setting up sterile field for picc insertion it was found that the lidocaine ampule that is in the sealed picc kits was empty, the neck of the ampule as well as the plastic safety cover were missing.Due to concern about glass fragments and missing lidocaine, entire kit was thrown away and a whole new insertion kit was opened.

• Brand Name: POWERPICC
• Type of Device: CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS
• Manufacturer (Section D): BARD ACCESS SYSTEMS, INC.; 605 north 5600 west; salt lake city UT 84116
• MDR Report Key: 13558886
• MDR Text Key: 285818553
• Report Number: 13558886
• Device Sequence Number: 1
• Product Code: LJS
• UDI-Device Identifier: 00801741101847
• UDI-Public: (01)00801741101847
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 01/31/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/18/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: CK000187B
• Device Catalogue Number: CK000187B
• Device Lot Number: 21OBA746
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/31/2022
• Event Location: Hospital
• Date Report to Manufacturer: 02/18/2022
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 21535 DA
• Patient Sex: Female