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

Model Number	S1275108FD1
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	01/26/2020
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 redu2216 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported on january 26th, staff performed an over the wire placement, removing a single lumen and replacing with a double lumen.Chest x-ray confirmed retained 3cg stylet.Facility stated they do not intend to retrieve the sytlet due to the patient's condition.No other information was provided.

• Brand Name: POWERPICC PROVENA 5F DL FT 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: 11203023
• Report Number: 3006260740-2020-21395
• Device Sequence Number: 19391120
• Product Code: LJS
• UDI-Device Identifier: 00801741154751
• UDI-Public: (01)00801741154751
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K051672
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 12/31/2020

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 Model Number: S1275108FD1
• Device Catalogue Number: S1275108FD1
• Device Lot Number: REDU2216
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/30/2020
• Initial Report FDA Received Date: 01/20/2021
• 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