MAUDE Adverse Event Report: BARD ACCESS SYSTEMS POWERPICC CATHETER 6F FULL TRAY (TRIPLE-LUMEN)(WITH MICROINTRODUCER) (WITH LIDOC; 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	12/31/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The information provided by bd 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 bd.The device has not been returned to the manufacturer for evaluation.A lot history review (lhr) of recv2321 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported that the picc was removed due to leaking.It was observed after removal, that it leaks when the red lumen is flushed at the hub where the catheter joins the hub.

• Brand Name: POWERPICC CATHETER 6F FULL TRAY (TRIPLE-LUMEN)(WITH MICROINTRODUCER) (WITH LIDOC
• 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: 8274413
• Report Number: 3006260740-2019-00077
• Device Sequence Number: 1501113
• Product Code: LJS
• UDI-Device Identifier: 00801741028229
• UDI-Public: (01)00801741028229
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K053501
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 01/24/2019

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: 3386108
• Device Lot Number: RECV2321
• Was Device Available for Evaluation?: No
• Event Location: Hospital
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/02/2019
• Initial Report FDA Received Date: 01/24/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1