MAUDE Adverse Event Report: BARD ACCESS SYSTEMS HICKMAN 9 FR DUAL-LUMEN CV CATHETER, CUTDOWN TRAY WITH SURECUFF TISSUE INGROWTH; PERCUTANEOUS, IMPLANTED, LONG TERM INTRAVASCULAR CATHETER

Model Number	0600340
Medical Device Problem Code	Suction Problem (2170)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/19/2018
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, at this time, for evaluation.A lot history review (lhr) of huas0718 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported that after use on the patient resistance was experienced during the aspiration test.There was no reported patient injury.
Additional Manufacturer Narrative
The following were reviewed as part of this investigation: patient severity, trend analysis, applicable previous investigation(s), sample (if available), applicable fmea documents, labeling, and applicable manufacture records.Based on a review of this information, the following was concluded: the complaint of difficulty aspirating is unconfirmed, problem could not be reproduced.The sample returned was one 9 fr dual lumen catheter with cuff.A 14 mm section of the distal end has been removed from the main catheter section.Blood residue is visible on the cuff.The matching ends of the catheter (main and trimmed section) match in pattern and appear to be trimmed using a sharpened instrument.Aspiration and flushing of the catheter using a 12 ml syringe revealed it to be patent without leaks.As no functional issue was found, the complaint is unconfirmed.A lot history review (lhr) of huas0718 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported that after use on the patient resistance was experienced during the aspiration test.There was no reported patient injury.

• Brand Name: HICKMAN 9 FR DUAL-LUMEN CV CATHETER, CUTDOWN TRAY WITH SURECUFF TISSUE INGROWTH
• Common Device Name: PERCUTANEOUS, IMPLANTED, LONG TERM INTRAVASCULAR CATHETER
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 7423344
• Report Number: 3006260740-2018-00669
• Device Sequence Number: 16586520
• Product Code: LJS
• UDI-Device Identifier: 00801741051760
• UDI-Public: (01)00801741051760
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K830233
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/12/2018

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: 0600340
• Device Catalogue Number: 0600330
• Device Lot Number: HUAS0718
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/08/2018
• Event Location: Hospital
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 06/11/2018
• Initial Report FDA Received Date: 04/11/2018
• Supplement Report FDA Received Date: 07/12/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1