BARD ACCESS SYSTEMS UNKNOWN PORT; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
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Catalog Number UNK PORT |
Device Problem
Device Contamination with Chemical or Other Material (2944)
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Patient Problem
No Patient Involvement (2645)
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Event Type
malfunction
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Manufacturer Narrative
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The lot number for the malfunction is unknown, therefore the manufacturing review could not be conducted.The device has not been returned for evaluation; therefore, the investigation is inconclusive for foreign material in the package as no objective evidence has been provided to confirm any alleged deficiency with the device.Based upon the available information, the definitive root cause is unknown.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 unknown port allegedly experienced device contamination with chemical or other material.This information was received from one source.This event did not involve a patient as there was no patient contact.The patient's age, weight, and gender were not provided.
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Search Alerts/Recalls
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