MAUDE Adverse Event Report: BARD ACCESS SYSTEMS POWERPICC SV CATHETER 4F FULL TRAY (DUAL-LUMEN); CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Model Number	N/A
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/02/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has not been returned to the manufacturer for evaluation, as the device was discarded after the event occurred.A lot history review (lhr) of recv2189 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported the catheter was placed in left upper arm, cephalic vein; 3 cm external length, securacath in place.Rn administered medication through the white port with no issues; white lumen was subsequently flushed with normal saline and heparin, no leakage noted.When the cap on the red port was changed and the red port was flushed with normal saline, leaking was immediately noted underneath the dressing at/around the securacath saturating the dressing.Of note, multiple doses of alteplase had been given for partial catheter occlusion on the following dates: 1/15, 1/20, 1/24, 1/27 and 1/28, with patency restored each time.Last chest x-ray done on 1/23 showed catheter tip in good position at cavoatrial junction.No other information provided.

• Brand Name: POWERPICC SV CATHETER 4F FULL TRAY (DUAL-LUMEN)
• 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: 8405957
• Report Number: 3006260740-2019-00521
• Device Sequence Number: 269254
• Product Code: LJS
• UDI-Device Identifier: 00801741027826
• UDI-Public: (01)00801741027826
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K102159
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/08/2019

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: 3274108
• Device Lot Number: RECV2189
• Was Device Available for Evaluation?: No
• Event Location: Hospital
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/13/2019
• Initial Report FDA Received Date: 03/08/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 16 YR
• Patient Weight: 62