MAUDE Adverse Event Report: BARD ACCESS SYSTEMS SOFT-CELL PC-2 DIALYSIS CATHETER KIT 12.5F X 19 CM (PRE-CURVED) (LONG-TERM); CATHETER, SUBCLAVIAN

Model Number	5534190
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/05/2018
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 catheter was implanted via the right internal jugular vein in (b)(6) 2014.Air infiltration was also reported when blood was being drawn.Poor blood removal in the catheter was observed, so urokinase and etc.Were applied to improve the blood flow in (b)(6) 2018.Heparin aspiration and saline flush prior usage of the catheter were performed with no problem on (b)(6) 2018.Heparin aspiration and saline flush prior usage of the catheter were performed successfully and the catheter was connected to the dialysis circuit.However, approximately five minutes post starting dialysis, air filtration was allegedly observed from the catheter into the extension tube connected between it and the dialysis circuit on (b)(6) 2017.The catheter was exchanged on (b)(6) 2018.There was no reported patient injury.
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.Residue was observed throughout the fibers of the cuff material.The catheter and extension legs were discolored yellow.The external portion of the d/l tubing was darker yellow than the subcutaneous section of the catheter.The printing on the extension legs was slightly worn.The luer adaptors were marred.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 arterial lumen.A microscopic examination of the leak site revealed that the catheter material around the hole was rough and granular, which is indicative of a tear.The hole in the tubing may be attributable to a combination of chemical degradation and mechanical stresses, such as pulling, twisting, and/or manipulating the d/l tubing at the bifurcation.As it was reported that the catheter was in place since (b)(67) 2014 and removed 3 ½ years later, the hole in the tubing must have developed over time and occurred during use.It is unknown what chemicals were used on or near the catheter.The product ifu provides information on chemicals that should not be used with the catheter.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 catheter was implanted via the right internal jugular vein in (b)(6) 2014.Air infiltration was also reported when blood was being drawn.Poor blood removal in the catheter was observed, so urokinase and etc.Were applied to improve the blood flow in (b)(6) 2018.Heparin aspiration and saline flush prior usage of the catheter were performed with no problem on (b)(6) 2018.Heparin aspiration and saline flush prior usage of the catheter were performed successfully and the catheter was connected to the dialysis circuit.However, approximately five minutes post starting dialysis, air filtration was allegedly observed from the catheter into the extension tube connected between it and the dialysis circuit on (b)(6) 2017.The catheter was exchanged on (b)(6) 2018.There was no reported patient injury.

• Brand Name: SOFT-CELL PC-2 DIALYSIS CATHETER KIT 12.5F X 19 CM (PRE-CURVED) (LONG-TERM)
• Common Device Name: CATHETER, SUBCLAVIAN
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 7318008
• Report Number: 3006260740-2018-00371
• Device Sequence Number: 151274
• 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 Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/26/2018

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: 5534190
• Device Catalogue Number: 5534190
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/13/2018
• Event Location: Hospital
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 03/28/2018
• Initial Report FDA Received Date: 03/06/2018
• Supplement Report FDA Received Date: 04/26/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1