MAUDE Adverse Event Report: BARD ACCESS SYSTEMS HICKMAN 9 FR DUAL-LUMEN CV CATHETER, CUTDOWN TRAY WITH SURECUFF TISSUE INGROWTH; CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Model Number	0600330
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/24/2018
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) review is not possible, as no manufacturing lot number has been provided by the complainant.Device not returned at this time.
Event or Problem Description
It was reported that the ¿patient was due iv flucloxacillin antibiotics made up into 20mls.When attempting to bolus the drug into the white port, liquid appeared to squirt out of the side of the actual line.On examination a small fracture approximately 2mm in length could be seen just below the clamp.¿ hickman catheter.No patient injury reported.
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 fractured catheter was confirmed and the cause appears to be use related.The product returned for evaluation was one 9 fr dual lumen 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 immediately distal of the clamping sleeve.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).An occlusion was observed distal to the burst site, and this may have contributed to the failure.Forceful flushing against an occlusion can cause this type of failure.An examination of the catheter structure revealed no potential damage/defect related to manufacture of the product.A lot history review (lhr) review is not possible, as no manufacturing lot number has been provided by the complainant.
Event or Problem Description
It was reported that the ¿patient was due iv flucloxacillin antibiotics made up into 20mls.When attempting to bolus the drug into the white port, liquid appeared to squirt out of the side of the actual line.On examination a small fracture approximately 2mm in length could be seen just below the clamp.¿ hickman catheter.No patient injury reported.

• Brand Name: HICKMAN 9 FR DUAL-LUMEN CV CATHETER, CUTDOWN TRAY WITH SURECUFF TISSUE INGROWTH
• 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: 7438564
• Report Number: 3006260740-2018-00728
• Device Sequence Number: 13743321
• Product Code: LJS
• UDI-Device Identifier: 00801741051753
• UDI-Public: (01)00801741051753
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K830233
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/17/2018

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: Health Professional
• Device Model Number: 0600330
• Device Catalogue Number: 0600330
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/20/2018
• Event Location: Hospital
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 05/14/2018
• Initial Report FDA Received Date: 04/17/2018
• Supplement Report FDA Received Date: 05/17/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1