BARD ACCESS SYSTEMS X-PORT ISP IMPLANTABLE PORT, GROSHONG SINGLE-LUMEN, 8F; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
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Catalog Number 7707540J |
Device Problem
Device Contaminated During Manufacture or Shipping (2969)
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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 catalog number identified has not been cleared in the us, but is similar to the x-port isp implantable port, groshong single-lumen, products that are cleared in the us.The pro code for the x-port isp implantable port, groshong single-lumen, products is identified.As the lot number for the device was not provided, a lot history review could not be performed.The sample was not returned to the manufacturer for inspection/evaluation; therefore, the investigation of the reported event is inconclusive for contaminated.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 7707540j port & catheter, implanted, subcutaneous, intravascular allegedly contaminated during manufacturing or shipping.This information was received from one source.This malfunction did not involve a patient as there was no patient contact.The age, weight and gender of the patient were not provided.
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Search Alerts/Recalls
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