MAUDE Adverse Event Report: BARD ACCESS SYSTEMS POWERPICC FT CATHETER WITH SHERLOCK 3CG TIP POSITIONING SYSTEM (TPS) STYLET 5F M; CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Model Number	N/A
Medical Device Problem Code	Material Frayed (1262)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	02/25/2020
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 redw3714 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
The rn placing the device reported, "on (b)(6) 2020; i attempted to place a picc line in the left brachial vein of a patient¿s arm.I was unable to advance the wire so i went to pull the wire out, and it felt as if the wire got stuck on the introducer needle, so i advanced the wire a bit and attempted to pull out the wire and introducer needle together and it would not come out.Then i removed the introducer needle and pulled gently back on the wire and as i was removing the wire, the wire was uncoiling and ended up snapping and lodging the tip portion of the wire into the patient¿s arm.I notified the patient immediately that there was a chance there was a piece of wire in her arm and we would possibly need to run some tests to see if that was truly there.I notified the doctor who was the physician for the day and he ordered a cta of the lue.Upon cta completion the wire was definitely seen.I filled out an incident report that day.Eventually surgery was performed on patient and the wire was removed from her arm.".

• Brand Name: POWERPICC FT CATHETER WITH SHERLOCK 3CG TIP POSITIONING SYSTEM (TPS) STYLET 5F M
• 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: 9916480
• Report Number: 3006260740-2020-01135
• Device Sequence Number: 2732184
• Product Code: LJS
• UDI-Device Identifier: 00801741034572
• UDI-Public: (01)00801741034572
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K091324
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 04/02/2020

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: Health Professional
• Device Expiration Date: 12/31/2020
• Device Model Number: N/A
• Device Catalogue Number: 1275108FD
• Device Lot Number: REDW3714
• Was Device Available for Evaluation?: No
• Event Location: Hospital
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/10/2020
• Initial Report FDA Received Date: 04/02/2020
• 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: Required Intervention