MAUDE Adverse Event Report: BARD ACCESS SYSTEMS VAS-CATH SOFT-CELL KIT 12.5 F X 19 CM [PRE-CURVED LONG TERM DUAL-LUMEN]; BLOOD ACCESS AND ACCESSORIES

Model Number	5534190
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	06/09/2017
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 leakage of blood from the junction of the extension tube was found during artificial dialysis.As the doctor suspected that the catheter may have been damaged, the catheter was removed from the patient in (b)(6).Artificial dialysis is currently performed with a shunt which was inserted previously.
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 was of a leak in the catheter was confirmed, and the damage appears to be associated with use of the device.One 19cm pre-curved soft-cell catheter was returned for investigation.The returned sample exhibited evidence of use.Blood residue was observed on the surecuff.The extension legs were discolored.The bifurcation material and the section of d/l tubing between the bifurcation and the cuff were also discolored.The threaded areas of the connectors also exhibited a lighter hue of the red and blue material.A functional test confirmed a leak in the catheter at the distal end of the bifurcation.A breach in the tubing allowed fluid to leak from the venous lumen when the catheter was pressurized.A microscopic examination of the leak site revealed that the catheter material around the hole was rough and granular, which is indicative of wear.The hole in the tubing may be attributable to a combination of chemical degradation and mechanical stresses, such as kinking.It is unknown what chemicals were used on or near the catheter.As it was reported that the catheter was in place since (b)(6) 2015 and removed 2 ½ years later, the hole in the tubing must have developed over time and occurred during use.The product ifu provides information on chemicals that should not be used with the catheter.
Event or Problem Description
It was reported that leakage of blood from the junction of the extension tube was found during artificial dialysis.As the doctor suspected that the catheter may have been damaged, the catheter was removed from the patient in july.Artificial dialysis is currently performed with a shunt which was inserted previously.

• Brand Name: VAS-CATH SOFT-CELL KIT 12.5 F X 19 CM [PRE-CURVED LONG TERM DUAL-LUMEN]
• Common Device Name: BLOOD ACCESS AND ACCESSORIES
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 6758896
• Report Number: 3006260740-2017-01189
• Device Sequence Number: 16577710
• Product Code: LFJ
• UDI-Device Identifier: 00801741012440
• UDI-Public: (01)00801741012440
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K871488
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/31/2017

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 Model Number: 5534190
• Device Catalogue Number: 5534190
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/02/2017
• Event Location: Hospital
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 08/29/2017
• Initial Report FDA Received Date: 08/01/2017
• Supplement Report FDA Received Date: 08/31/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1