MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 POWERPICC PROVENA SOLO 5F TL MBP KIT W/GUARDIVA PC; 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	06/27/2021
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 refn0851 showed no other similar product complaint(s) from this lot number.Device not returned for evaluation.
Event or Problem Description
It was reported via ms&s "he states placed 5f tl power picc on (b)(6) 2021.She reports that the guidewire with the 3cg magnet broke off into the patient during the insertion of the picc.A cardiac cath was performed to attempt to retrieve the broken off piece from the patient but was unsuccessful.They are transferring the patient to another facility.No adverse effects noted to patient as of today." ms&s response "discussed possible causes such as accidently nicking the stiffening stylet when cutting the picc, pulling the guidewire back while the needle is held in place or guidewire getting hung up on a valve.Advised the customer to hold on the to guidewire and any other parts of the kit he still has in order to return them to complaints if required.Case forwarded to product complaints via email.".

• Brand Name: POWERPICC PROVENA SOLO 5F TL MBP KIT W/GUARDIVA PC
• 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: 12214433
• Report Number: 3006260740-2021-02904
• Device Sequence Number: 14141699
• Product Code: LJS
• UDI-Device Identifier: 00801741155024
• UDI-Public: (01)00801741155024
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K072230
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/01/2021

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: S1395108D3
• Device Lot Number: REFN0851
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/28/2021
• Initial Report FDA Received Date: 07/22/2021
• 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