MAUDE Adverse Event Report: BARD ACCESS SYSTEMS BARD ACCESS SYSTEMS POWER PICC HF CATHETER; CATHETER, INTRAVASCULAR, THERAPEUTIC, LONG-TERM GREATER THAN 30 DAYS

Model Number	1385108Q
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/24/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
Picc line developed a leak after 3 days.Hole seen in line.Fda safety report id# (b)(4).

• Brand Name: BARD ACCESS SYSTEMS POWER PICC HF CATHETER
• Common Device Name: CATHETER, INTRAVASCULAR, THERAPEUTIC, LONG-TERM GREATER THAN 30 DAYS
• Manufacturer (Section D): BARD ACCESS SYSTEMS ; salt lake city UT 84116
• MDR Report Key: 9764038
• Report Number: MW5093347
• Device Sequence Number: 16758353
• Product Code: LJS
• UDI-Device Identifier: 00801741034640
• UDI-Public: 0100801741034640
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Reporter Type: Voluntary
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 02/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/31/2020
• Device Model Number: 1385108Q
• Device Catalogue Number: 1385108Q
• Device Lot Number: 1385108Q
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/26/2020
• 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
• Patient Age: 74 YR
• Patient Weight: 61