MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 BARD MYPICC KIT; CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Model Number	N/A
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	11/04/2020
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 19lbr460 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported via medwatch "during picc placement it was noticed that the stylet was fractured when removed; 2cm loss of microwire upon removal, presumed to be in patient as foreign body".
Event or Problem Description
It was reported via medwatch "during picc placement it was noticed that the stylet was fractured when removed; 2cm loss of microwire upon removal, presumed to be in patient as foreign body".

• Brand Name: BARD MYPICC 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: 11109134
• Report Number: 3006260740-2020-21149
• Device Sequence Number: 1059684
• Product Code: LJS
• UDI-Device Identifier: 00801741104190
• UDI-Public: (01)00801741104190
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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,Followup
• Report Date (Section B): 01/25/2021

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: CK000452
• Device Lot Number: 19LBR460
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/07/2020
• Supplement Date Received by Manufacturer: 01/25/2021
• Initial Report FDA Received Date: 01/04/2021
• Supplement Report FDA Received Date: 03/25/2021
• 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