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

Model Number	5533190
Medical Device Problem Code	Material Frayed (1262)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/20/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No medical records or medical images have been made available to the manufacturer.As the lot number for the device was provided, a review of the device history records is currently being performed.The device is pending return to the manufacturer for evaluation.The investigation of the reported event is currently underway.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.
Event or Problem Description
It was reported that after inserting the guidewire through the needle, the distal tip of the guidewire was allegedly entangled.There was no reported patient injury.
Event or Problem Description
It was reported that after inserting the guidewire through the needle, the distal tip of the guidewire was allegedly entangled.There was no reported patient injury.
Additional Manufacturer Narrative
Manufacturing review: the device history records have been reviewed and this lot met all release criteria.There was nothing found to indicate there was a manufacturing related cause for this event.This is the only complaint reported to date for this lot number and failure mode.Labeling review: the review of the ifu (instructions for use), indications, warnings, precautions, cautions, possible complications, and contraindications showed that the product labeling is adequate.Investigation summary: one guidewire and one introducer needle, reportedly from a d/l softcell hemodialysis kit, were returned for evaluation.The outer wire of the guidewire was noted to be stretched, with the distal tip of the inner core wire visible inside of the outer wire in the stretched portion.Tissue/residue of use was noted at the distal end of the stretched portion, immediately proximal to the j-tip of the guidewire.No anomalies were noted on the introducer needle.Based on the finding that the guidewire was stretched, the investigation is confirmed for the reported frayed guidewire.Per the evaluation results, tissue/residue of use was noted at the distal end of the stretched portion of the guidewire.It is possible that the tissue on the guidewire contributed to the reported event, as retraction of the guidewire against the needle bevel can contribute to the frayed guidewire issue.However, the definitive root cause could not be determined based upon available information.It is unknown whether patient and/or procedural issues contributed to the reported event.

• Brand Name: SOFT-CELL PC 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: 7539339
• Report Number: 3006260740-2018-01071
• Device Sequence Number: 16598797
• Product Code: LFJ
• UDI-Device Identifier: 00801741012396
• UDI-Public: (01)00801741012396
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K871488
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/04/2019

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: 5533190
• Device Catalogue Number: 5533190
• Device Lot Number: REBX0774
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/31/2018
• Initial Date Received by Manufacturer: 05/02/2018
• Supplement Date Received by Manufacturer: 12/07/2018
• Initial Report FDA Received Date: 05/23/2018
• Supplement Report FDA Received Date: 01/04/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1