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

Catalog Number	0600330
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/22/2016
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 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 a leaking chronic catheter was confirmed and the cause appears to be use related.The product returned for evaluation was one 9fr d/l hickman catheter.The damage observed in the returned sample was characteristic of over-pressurization (burst) damage.This can occur through the use of syringes smaller than 10ml, by flushing against an occlusion, or due to excessive force applied during infusion procedures.The returned product sample was evaluated and a split was observed just distal of the bifurcation, on the white-lured lumen side.This catheter damage was typical of a burst, and the characteristics observed which supported this type of failure included: 'c' shaped split.Tensile weakness at the fracture site (due to material ballooning prior to burst).Granular fracture surface texture (typical of tearing failure modes).The catheter material was visibly lighter in color at the fracture site.An examination of the catheter structure revealed no potential damage/defect related to manufacture of the product.Reference (b)(4) for further information about this failure type.The product nursing guide provides the following guidance pertaining to occluded or partially occluded catheters: ¿to avoid catheter rupture, do not force entire amount into catheter if strong resistance is felt.¿ a lot history review (lhr) is not possible since a valid lot number was not provided by the complainant.
Event or Problem Description
As reported by the facility, the hickman catheter was found broken at one of the extension legs.The catheter was then handled and removed according to hospital protocol.No harm to patient reported.

• 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: 6428453
• Report Number: 3006260740-2017-00294
• Device Sequence Number: 10842292
• Product Code: LJS
• UDI-Device Identifier: 00801741051753
• UDI-Public: (01)00801741051753
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: K830233
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date (Section B): 03/23/2017

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 Catalogue Number: 0600330
• Device Lot Number: HUYH006 (INVALID)
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/13/2017
• Was the Report Sent to FDA?: No
• Event Location: Hospital
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/13/2017
• Initial Report FDA Received Date: 03/23/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1