MAUDE Adverse Event Report: BARD ACCESS SYSTEMS POWERPICC S/L; CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Model Number	3274118
Health Effect - Clinical Code	Thrombus (2101)
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient's mother reports her daughter developed a dvt after her first picc was inserted.The picc was removed and a new picc was placed in the other arm.The reported dvt was in the subclavian vein and was treated with lovenox injection.The patient's mother reports she (the patient) has continued to develop superficial clots at the site is on ongoing lovenox until a different catheter can be placed.

• Brand Name: POWERPICC S/L
• Common Device Name: CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 7487682
• Report Number: 3006260740-2018-00891
• Device Sequence Number: 1718068
• Product Code: LJS
• UDI-Device Identifier: 00801741027840
• UDI-Public: (01)00801741027840
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date (Section B): 05/04/2018

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: 3274118
• Device Catalogue Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Event Location: Hospital
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/04/2018
• 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