MAUDE Adverse Event Report: BARD ACCESS SYSTEMS SFTCEL-PC RJ 19CM KIT; SOFT CELL D/L DIALYSIS

Model Number	5534190
Medical Device Problem Codes	Component Incompatible (1108); Material Frayed (1262)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/16/2019
Type of Reportable Event	Malfunction
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.Investigation summary: one guidewire and one introducer needle were returned for evaluation.The guidewire was received inserted in the introducer needle.The guidewire was able to be removed from the needle, with residue noted on the portion of the guidewire that had been inside the needle.When viewed under magnification, unraveling/stretching of the outer coil wire was noted near the residue.Based on this finding, the investigation is confirmed for the reported advancement issue, specifically due to a frayed guidewire.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.Potential contributing factors include insertion technique, insufficient-sized skin nick and retraction against the introducer needle bevel.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.(expiry date: 07/2021).
Event or Problem Description
It was reported that during placement of dialysis catheter, the guidewire allegedly was unable to advance through the introducer needle.It was further reported that the introducer needle and the guidewire were removed together.Reportedly, another introducer needle and guidewire was used to placed the initial dialysis catheter provided in the kit.There was no reported patient injury.

• Brand Name: SFTCEL-PC RJ 19CM KIT
• Common Device Name: SOFT CELL D/L DIALYSIS
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 8450148
• Report Number: 3006260740-2019-00670
• Device Sequence Number: 3014224
• Product Code: LFJ
• UDI-Device Identifier: 00801741012440
• UDI-Public: (01)00801741012440
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K030277
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/25/2019

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: 5534190
• Device Catalogue Number: 5534190
• Device Lot Number: RECU0622
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/12/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/08/2019
• Initial Report FDA Received Date: 03/25/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1