Catalog Number 0606150J |
Device Problems
Fracture (1260); Material Frayed (1262); Peeled/Delaminated (1454)
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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 device has not been returned for evaluation; therefore, the investigation is inconclusive for material frayed 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 0606150j.Implantable port allegedly experienced material frayed.This report was received from a single source.This event did involve patient with no reported patient injury.The patients age, weight and gender were not provided.
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Manufacturer Narrative
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H10: the lot number was provided and a lot history review was performed.The sample was returned for evaluation, a photo was provided.Therefore, the investigation is confirmed for the fraying of the guidewire as well as the break in the inner core wire that was observed.Based upon the available information, the definitive root cause for this event is unknown.The device is labeled for single use.H10: g4.H11: g1, h2, h6 (results and conclusion).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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Event Description
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This report summarizes one malfunction.A review of the reported information indicated that model 0606150j.Implantable port allegedly experienced material frayed.This report was received from a single source.This event did involve patient with no reported patient injury.The patients age, weight and gender were not provided.
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Manufacturer Narrative
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H10: the lot number was provided and a lot history review was performed.The sample was returned for evaluation, a photo was provided and is currently underway review.The company is still investigating the issue at this time.The device is labeled 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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Event Description
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This report summarizes one malfunction.A review of the reported information indicated that model 0606150j.Implantable port allegedly experienced material frayed.This report was received from a single source.This event did involve patient with no reported patient injury.The patients age, weight and gender were not provided.
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Search Alerts/Recalls
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