MAUDE Adverse Event Report: BARD ACCESS SYSTEMS POWERPICC SOLO CATHETER 5F RADIOLOGY BASIC TRAY (DUAL-LUMEN) (135CM NITINOL GW); CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Model Number	N/A
Health Effect - Clinical Codes	Pain (1994); Swelling (2091)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The information provided by bard represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bard.The device has not been returned to the manufacturer for evaluation, as the device remains in the patient.A lot history review (lhr) of reby2050 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
Patient called reporting that her left hand and entire left arm are both swollen and painful.Three days earlier an interventional radiologist placed a powerpicc solo picc line for administration of tpn.Ms&s advised her to see her doctor as soon as possible.

• Brand Name: POWERPICC SOLO CATHETER 5F RADIOLOGY BASIC TRAY (DUAL-LUMEN) (135CM NITINOL GW)
• 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: 7346913
• Report Number: 3006260740-2018-00457
• Device Sequence Number: 69908
• Product Code: LJS
• UDI-Device Identifier: 00801741028120
• UDI-Public: (01)00801741028120
• Combination Product (Y/N): N
• PMA/510(K) Number: K072230
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Patient
• Type of Report: Initial
• Report Date (Section B): 03/16/2018

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 Model Number: N/A
• Device Catalogue Number: 3295335
• Device Lot Number: REBY2050
• Was Device Available for Evaluation?: No
• Event Location: Home
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/16/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1