MAUDE Adverse Event Report: BARD ACCESS SYSTEMS SOFT-CELL STRAIGHT CHRONIC DUAL-LUMEN CATHETER KIT; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR

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	10/19/2018
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.This is the only complaint reported to date for this lot number and failure mode.Investigation summary:one guidewire (with guidewire straightener and hoop) and one introducer needle were returned for evaluation.It was noted that the guidewire was bent with its outer coil wire stretched at the distal end.When viewed under magnification, slight wear was noted to the needle bevel.The guidewire could not be inserted into the introducer needle due to the identified stretching.Based on these findings, the investigation is confirmed for the reported guidewire advancement issue, specifically due to a frayed guidewire.Per the evaluation results, wear was noted to the needle bevel.This can occur as a result of retraction of the guidewire against the needle bevel.Therefore, it's possible that the guidewire was damaged as a result of retraction against the needle bevel.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.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.(expiration date: 07/2021).
Event or Problem Description
It was reported that during the procedure the guidewire became allegedly stuck, therefore, the health care provider attempted to manipulate the guidewire unsuccessfully.Reportedly, the device was removed.Another kit was opened to complete the procedure.There was no reported patient injury.

• Brand Name: SOFT-CELL STRAIGHT CHRONIC DUAL-LUMEN CATHETER KIT
• Common Device Name: PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 8341781
• Report Number: 3006260740-2019-00280
• Device Sequence Number: 1717750
• 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
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/14/2019

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: 11/21/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/18/2019
• Initial Report FDA Received Date: 02/14/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1