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

Model Number	CK000187B
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/29/2022
Type of Reportable Event	Malfunction
Event or Problem 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
• Common Device Name: 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
• Report Number: 13558886
• Device Sequence Number: 4195070
• Product Code: LJS
• UDI-Device Identifier: 00801741101847
• UDI-Public: (01)00801741101847
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 01/31/2022
• Report Date (Section F): 01/31/2022

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 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
• Event Location: Hospital
• Date Report to Manufacturer: 02/18/2022
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/18/2022
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Female
• Date Report Sent to FDA: 01/31/2022