BARD ACCESS SYSTEMS M.R.I. IMPLANTABLE PORT, GROSHONG SINGLE-LUMEN, KIT, 8F; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
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Model Number 0602833 |
Device Problems
Fracture (1260); Material Separation (1562); Material Deformation (2976)
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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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As the lot number for the device was provided, a lot history review was performed.The sample was returned to the manufacturer for evaluation.The investigation is confirmed for material deformation, material separation, and fracture.A definitive root cause for the reported event could not be determined.The device is labeled for single use.
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Event Description
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This report summarizes one malfunction.A review of the reported information indicated that model 0602833 port & catheter, implanted, subcutaneous, intravascular allegedly experienced fracture, material separation and material deformation.This information was received from one source.The malfunction involved a patient with no known impact to the patient.The patient age, sex and weight were not provided.
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Search Alerts/Recalls
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