Model Number AT75222 |
Device Problems
Device Markings/Labelling Problem (2911); Material Deformation (2976)
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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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The lot number for the reported malfunction was provided, therefore a lot history review will be performed.The device was not returned for evaluation, however one video was provided for review.The company is still investigating the issue at this time.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 indicates that model at75222 pta balloon dilatation catheter experienced material deformation.This report was received from one source.One patient was involved with no reported patient injury.The patient's age, weight, and gender were not provided.
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Manufacturer Narrative
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H10: the lot number for the reported malfunction was provided, therefore a lot history review was performed.The device was not returned for evaluation, however one video was provided for review.The investigation of the video unconfirmed the alleged malfunction of mislabeled product.Based on the provided information, a definitive root cause of the event could not be determined.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 indicates that model at75222 pta balloon dilatation catheter experienced product mislabeling.This report was received from one source.One patient was involved with no reported patient injury.The patient's age, weight, and gender were not provided.
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Search Alerts/Recalls
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