Catalog Number 8806061 |
Device Problems
Burst Container or Vessel (1074); Material Discolored (1170); Fracture (1260)
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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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For the reported event, the devices was not returned to bd.An x-ray image and photo was provided and is currently underway review.The company is still investigating the issue at this time.The device was labeled for single use.The information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.
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Event Description
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This report summarizes one malfunction.A review of the reported information indicated that model 8806061.Implantable port allegedly experienced burst container or vessel.This report was received from a single source.This malfunction did involve patient with no reported patient injury.The patient is 65 years of age, the gender is male, and the weight is 60 kgs.
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Event Description
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This report summarizes one malfunction.A review of the reported information indicated that model 8806061.Implantable port allegedly experienced burst container or vessel.This report was received from a single source.This malfunction did involve patient with no reported patient injury.The patient was 65 years old, the gender was male and the weight was 60 kg.
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Manufacturer Narrative
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H10: the lot number for the device was not provided and a lot history review could not be performed.For the one reported malfunction, the device was not returned for evaluation.An x-ray image and electronic photo was provided and reviewed.Based on the photo review, a partial fracture in the catheter and catheter discoloration can be confirmed.The definitive root cause could not be determined based upon available information.The device was labelled for single use.H11:section a through f - the information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.
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Search Alerts/Recalls
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