Model Number U8130330 |
Device Problems
Break (1069); Device-Device Incompatibility (2919)
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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 was provided, therefore a lot history review was performed.The sample was returned to the manufacturer for evaluation.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 indicated that model u8130330 pta balloon dilatation catheter allegedly was unable to load over the guidewire and broke.This information was received from one source.This malfunction involved a patient with no consequences.Age, weight, and gender of the patient was 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 returned for evaluation.Therefore the investigation is confirmed for the reported device-device incompatibility.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 u8130330 pta balloon dilatation catheter allegedly experienced device-device incompatibility.This information was received from one source.This malfunction involved a patient with no consequences.Age, weight, and gender of the patient was not provided.
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Search Alerts/Recalls
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