MAUDE Adverse Event Report: BARD ACCESS SYSTEMS POWERHICKMAN 8F SINGLE-LUMEN POLYURETHANE CATHETER WITH SURECUFF INGROWTH CUFF (; CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Model Number	0805815
Health Effect - Clinical Code	Pain (1994)
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 rebt2106 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported that the patient has a powerhickman and she is having pain along with difficulty obtaining blood return at times.She reports not using heparin to lock the catheter she also reports that the clamp is too bulky.Ms&s explained that the powerhickman cvc is an open ended catheter and that it is recommended to lock the catheter with heparin once daily to weekly to prevent complications.Ms&s discussed causes of one way occlusions and recommended that she speak with her physician about administration of cathflo or a dye study to check catheter function.

• Brand Name: POWERHICKMAN 8F SINGLE-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: 7438649
• Report Number: 3006260740-2018-00723
• Device Sequence Number: 1030094
• Product Code: LJS
• UDI-Device Identifier: 00801741036675
• UDI-Public: (01)00801741036675
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K061179
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Patient
• Type of Report: Initial
• Report Date (Section B): 04/17/2018

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: Lay User/Patient
• Device Model Number: 0805815
• Device Catalogue Number: 0805815
• Device Lot Number: REBT2106
• 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: 04/17/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1