MAUDE Adverse Event Report: BARD ACCESS SYSTEMS DOME SUBQ PORT, HICKMAN W; IMPLANTABLE PORT

Model Number	0602870
Medical Device Problem Codes	Component Incompatible (1108); Material Frayed (1262)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/08/2018
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.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 were returned for evaluation.Stretching was noted to the outer coil wire with the distal ends of the inner core wires protruding from the stretched portion.When viewed under magnification, wear and use residue were identified at the tip of the introducer needle bevel.Based on the findings, the investigation is confirmed for the reported guidewire advancement issue, specifically due to a frayed guidewire.It is likely that the identified frayed guidewire issue was perceived as an advancement issue, as it would prevent the wire from moving normally.Additionally, per the evaluation results, wear and use residue were identified at the tip of the introducer needle bevel.These are characteristics typical of retraction of the guidewire against the needle bevel.Therefore, it is possible that damage due to retraction during use contributed to the reported and identified issues.However, the definitive root cause could not be determined based upon available information.
Event or Problem Description
It was reported that the guide wire allegedly got stuck after the guide wire passed through the needle and did not withdraw or advance any further.It was further alleged that the guide wire and needle were removed from the patient as a single unit and it was deemed necessary to use another kit and puncture the central vein of the patient.

• Brand Name: DOME SUBQ PORT, HICKMAN W
• Common Device Name: IMPLANTABLE PORT
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 8283564
• Report Number: 3006260740-2019-00105
• Device Sequence Number: 16658186
• Product Code: LJT
• UDI-Device Identifier: 00801741025778
• UDI-Public: (01)00801741025778
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K880571
• 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): 01/28/2019

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: 0602870
• Device Catalogue Number: 0602870
• Device Lot Number: REAY2327
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/03/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/04/2019
• Initial Report FDA Received Date: 01/28/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 26 YR