BARD ACCESS SYSTEMS CHRONO TITANIUM PORT; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
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Model Number 0605510 |
Device Problems
Component Incompatible (1108); Material Frayed (1262)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Type
malfunction
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Manufacturer Narrative
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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.
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Event Description
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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.
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Search Alerts/Recalls
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