MAUDE Adverse Event Report: BARD ACCESS SYSTEMS HICKMAN HEMODIALYSIS/APHERESIS CATHETER 13.5F DUAL-LUMEN CATHETER, 45CM OVERALL; CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Model Number	0600450
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/08/2018
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 rezg1488 showed no other similar product complaint(s) from this lot number.Device not returned at this time.
Event or Problem Description
It was reported by the facility that they had a hickman catheter that had multiple holes in it.They stated the catheter had two holes in the blue lumen and one in the red lumen prior to the y-site.No patient injury reported.
Additional Manufacturer Narrative
The following were reviewed as part of this investigation: patient severity, frequency 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 leak in the extension legs was confirmed, and the damaged appeared to be use related.One hickman dialysis catheter was returned for investigation.Evidence of use was observed on the sample.Blood residue was visible within the fibers of the cuff.Debris was observed on the clamps.A functional test revealed spraying leaks from each extension leg.The leaks were located between the bifurcation and the extension leg oversleeve.The extension legs were cut open to examine the leak sites within the lumen.Impressions from what appeared to be the coils of a guidewire were visible around the hole in the extension leg with the blue luer adaptor.Due to the condition of the sample, it appeared that the hickman dialysis catheter was damaged during use.The holes may have been created if the extension legs were clamped over the guidewire.The product ifu states, ¿avoid accidental device contact with sharp instruments and mechanical damage to the catheter material.¿ the ifu also states, ¿avoid perforating, tearing or fracturing the catheter when using a guidewire.¿ a lot history review (lhr) of rezg1488 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported by the facility that they had a hickman catheter that had multiple holes in it.They stated the catheter had two holes in the blue lumen and one in the red lumen prior to the y-site.No patient injury reported.

• Brand Name: HICKMAN HEMODIALYSIS/APHERESIS CATHETER 13.5F DUAL-LUMEN CATHETER, 45CM OVERALL
• 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: 7224849
• Report Number: 3006260740-2018-00061
• Device Sequence Number: 1023066
• Product Code: LJS
• UDI-Device Identifier: 00801741037443
• UDI-Public: (01)00801741037443
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K830233
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/29/2018

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: 0600450
• Device Catalogue Number: 0600450
• Device Lot Number: REZG1488
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/08/2018
• Event Location: Hospital
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 03/05/2018
• Initial Report FDA Received Date: 01/29/2018
• Supplement Report FDA Received Date: 03/29/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1