MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 POWERPICC SOLO 5F TL MAX BARRIER PLUS KIT; CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Model Number	N/A
Medical Device Problem Code	Migration or Expulsion of Device (1395)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	04/19/2021
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 rees0386 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported via medwatch "patient's brachial vessel was accessed using the safety needle supplied in the bard picc (peripherally inserted central catheter) kit.Blood return from the needle was positive and the guidewire was introduced through the needle.The needle was then removed from the patient's vessel, leaving the guidewire in place.I then made a tiny incision right above the guidewire to allow the dilator/introducer to be placed.I threaded the guidewire into the needle introducer and began to apply pressure to advance the introducer into the vessel.As i continued to apply pressure to the introducer, the guidewire advanced into the vessel as well.I removed the entire introducer since i didn't see the wire, and was unable to see the guidewire.I applied pressure to stop the bleeding and then ultrasound the patient's area to confirm the wire was in fact in the patient's vasculature.".

• Brand Name: POWERPICC SOLO 5F TL MAX BARRIER PLUS KIT
• Common Device Name: CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS
• Manufacturer (Section D): C.R. BARD, INC. (BASD) -3006260740; 605 north 5600 west; salt lake city 84116
• MDR Report Key: 12144192
• Report Number: 3006260740-2021-02715
• Device Sequence Number: 4215236
• Product Code: LJS
• UDI-Device Identifier: 00801741154812
• UDI-Public: (01)00801741154812
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: K072230
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/29/2021

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?: No
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: S1395108D1
• Device Lot Number: REES0386
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/21/2021
• Initial Report FDA Received Date: 07/09/2021
• 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
• Patient Age: 41 YR