MAUDE Adverse Event Report: BARD ACCESS SYSTEMS POWERHICKMAN 9.5F DUAL-LUMEN POLYURETHANE CATHETER WITH SURECUFF INGROWTH CUFF; CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Model Number	0805915
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
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.A lot history review (lhr) of rebw0429 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
The facility has been using the power hickman for approx.3 months and have seen 4 cases of difficulty removing the max zero cap with at least one case of hub crack.They confirmed they use alcohol with 15 sec scrub and 15 sec dry before attaching the max zero cap.The patient population are pedi cancer patients.They have been able to repair before pulling the lines.This file is being opened for the placement date of (b)(6) 2017.

• Brand Name: POWERHICKMAN 9.5F DUAL-LUMEN POLYURETHANE CATHETER WITH SURECUFF INGROWTH CUFF
• 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: 7278784
• Report Number: 3006260740-2018-00236
• Device Sequence Number: 10804069
• Product Code: LJS
• UDI-Device Identifier: 00801741036699
• UDI-Public: (01)00801741036699
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K061179
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 02/16/2018

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: 0805915
• Device Catalogue Number: 0805915
• Device Lot Number: REBW0429
• 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: 02/16/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1