MAUDE Adverse Event Report: BARD ACCESS SYSTEMS POWERPICC 6F RADIOLOGY BASIC TRAY (DUAL-LUMEN) (135 CM GUIDEWIRE); CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Model Number	N/A
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	03/25/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device has not been returned to the manufacturer for evaluation.A lot history review (lhr) of recw0499 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported one of the mo trainee was doing the picc insertion.Apparently the guide wire tip is caught at the deep axilla region.Most of the guidewire were removed except a portion of the flexible tip which was still lodged in the muscle.This can be seen under ultrasound.The picc procedure was completed by inserting it into patient left arm.Patient is stable , no reaction.

• Brand Name: POWERPICC 6F RADIOLOGY BASIC TRAY (DUAL-LUMEN) (135 CM GUIDEWIRE)
• Common Device Name: CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 8556972
• Report Number: 3006260740-2019-01200
• Device Sequence Number: 2169281
• Product Code: LJS
• UDI-Device Identifier: 00801741028007
• UDI-Public: (01)00801741028007
• Combination Product (Y/N): N
• Initial Reporter Country: SN
• PMA/510(K) Number: K050931
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 04/26/2019

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?: Yes
• Operator of Device: Other
• Device Model Number: N/A
• Device Catalogue Number: 3276135
• Device Lot Number: RECW0499
• Was Device Available for Evaluation?: No
• Event Location: Hospital
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/05/2019
• Initial Report FDA Received Date: 04/26/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Disability