MAUDE Adverse Event Report: BARD ACCESS SYSTEMS CHRONO TITANIUM PORT; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR

Model Number 0605510

Device Problems Component Incompatible (1108); Material Frayed (1262)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

The lot number was provided and the lot history review was performed.One introducer needle and one guide wire were returned for evaluation.The investigation is unconfirmed for guide wire stuck in introducer needle, as the proximal end of the guide wire was successfully passed through the introducer without substantial resistance.However, the investigation is confirmed for guidewire unraveling, as unwinding of the guide wire was observed during microscopic visual evaluation.Also, there was substantial residue observed on the surface of the guide wire originally embedded within the introducer needle shaft.This is consistent with characteristics of attempts to retract the guidewire through introducer needle.The definitive root cause could not be determined based upon available information.The device is labeled for single use.

Event Description

This report summarizes one (1) malfunction.A review of the reported information indicated that model 0605510ce port & catheter allegedly experienced an incompatible component and material frayed.This information was received from one source.The malfunction involved a patient with no known impact to the patient.The patient¿s age, weight, and gender were not provided.

• Brand Name: CHRONO TITANIUM PORT
• Type of Device: PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• Manufacturer (Section G): BARD REYNOSA S.A. DE C.V.; blvd montebello #1; parque industrial colonial; reynosa tamaulipas 88780 ; MX 88780
• Manufacturer Contact: judith ludwig ; 1625 w 3rd st.; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 8822592
• MDR Text Key: 152072397
• Report Number: 3006260740-2019-02180
• Device Sequence Number: 1
• Product Code: LJT
• UDI-Device Identifier: 00801741025969
• UDI-Public: (01)00801741025969
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/24/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/24/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 0605510
• Device Catalogue Number: 0605510CE
• Device Lot Number: RECX1895
• Date Manufacturer Received: 06/30/2019
• Type of Device Usage: Initial
• Patient Sequence Number: 1