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	3274108
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/07/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has not been returned, at this time, to the manufacturer for evaluation.A lot history review (lhr) of rect2465 showed no other similar product complaint(s) from this lot number.The catheter is being sent to (b)(4) to evaluate whether the securacath may have been a contributing factor; they will then forward it to bard following their investigation.
Event or Problem Description
It was reported the picc was placed in the left upper arm, left basilica vein with 6cm external length.The catheter was secured with securacath.It was stated that the patient was taken to medical imaging for ct scan.Picc red lumen was flushed and blood return obtained.Tubing from the power injector was connected to the picc.Shortly after contrast administration was started the patient reported leaking on his arm.On inspection, leaking at the site was noted.The patient was returned to his room.Picc was removed and a peripheral iv was placed; patient was then taken back to medical imaging and contrast was given through the peripheral iv to complete the ct scan.Peripheral iv placed; delay in completing ct scan.Patient was receiving parenteral nutrition which had to be stopped until a new picc could be placed on monday, (b)(6).

• 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: 8028987
• Report Number: 3006260740-2018-03073
• Device Sequence Number: 1379604
• 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: 2018
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 11/01/2018

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: 3274108
• Device Catalogue Number: 3274108
• Device Lot Number: RECT2465
• Was Device Available for Evaluation?: No
• Event Location: Hospital
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/09/2018
• Initial Report FDA Received Date: 11/01/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 17 YR
• Patient Weight: 52