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

Model Number	N/A
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/05/2017
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 manufacturer has received the sample and will evaluate.Results are expected soon.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, because air was drawn from the line, the line was inspected and a split was found in the hub.The catheter had been implanted about two years and a half earlier.No patient harm was reported.
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, 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 split in the catheter was confirmed and the cause appeared to be use related.The product returned for evaluation was a 19 cm soft-cell vas-cath dialysis catheter.The catheter had been cut near the cuff and the distal segment was not returned for evaluation.Gross visual evaluation of the sample showed that the extension legs were discolored a brown/orange color and contained several permanent clamp impressions.Further examination of the catheter revealed a short circumferentially-aligned split in the catheter at the interface of the catheter and molded joint.Microscopic examination of the split revealed that the catheter body had torn from the molded joint as the fracture surface was rough, granular, and tapered inwards towards the inner lumen surface.Further examination of the region showed that the split in the catheter was constrained to just one side of the catheter.Tactile evaluation revealed a preferential kink at the same location as the observed split.This preferential kink, the observed damage features, and the location of damage, were all characteristic of damage accumulated through repeated kinking of the catheter at the molded joint and can be avoided by limiting the number and degree of sharp kinking on 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, because air was drawn from the line, the line was inspected and a split was found in the hub.The catheter had been implanted about two years and a half earlier.No patient harm was reported.

• Brand Name: SOFT-CELL PC-2 DIALYSIS CATHETER KIT 12.5F X 19 CM DL(PRE-CURVED) (LONG-TERM)
• 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: 6527419
• Report Number: 3006260740-2017-00530
• Device Sequence Number: 1148804
• 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: 2017
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/25/2017

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: N/A
• Device Catalogue Number: 5534190
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/19/2017
• Event Location: Hospital
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 04/19/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/27/2017
• Supplement Report FDA Received Date: 05/25/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 70 YR