Model Number U4150322 |
Device Problem
Packaging Problem (3007)
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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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As the lot number for the device was provided, a lot history review is currently underway.The sample was not returned to the manufacturer for inspection/evaluation however, photos were provided for review.The investigation of the reported malfunction is currently underway.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 u4150322 pta balloon dilatation catheter allegedly experienced packaging problem.This information was received from one source.The one reported malfunction involved one patient with no consequences.The age, sex and weight of the patient was not provided.
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Manufacturer Narrative
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H10: the lot number for the device was provided and a lot history review was performed.The sample was not returned to the manufacturer for inspection/evaluation; however, three images were provided for review.The investigating is inconclusive for the reported packaging problem.Based upon the available information, the definitive root cause for this event is unknown.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 u4150322 pta balloon dilatation catheter allegedly experienced packaging problem.This information was received from one source.The one reported malfunction involved one patient with no consequences.The age, sex and weight of the patient were not provided.
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Search Alerts/Recalls
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