Catalog Number 1716000J |
Device Problem
Material Frayed (1262)
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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 this malfunction is unknown, therefore the manufacturing review could not be conducted.The device for this malfunction has been returned to the manufacturer for evaluation.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 171600j implanted powerport allegedly experienced frayed guidewire.This information was received from one source.This malfunction involved one patient with no consequences.The patient is (b)(6) year old male and weight was not provided.
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Manufacturer Narrative
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H10: the lot number for this malfunction is unknown, therefore the manufacturing review could not be conducted.The device was returned for evaluation and the investigation unconfirmed for reported malfunction.A definitive root cause 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 indicated that model 171600j implanted powerport allegedly experienced frayed guidewire.This information was received from one source.This malfunction involved one patient with no consequences.The patient is 65 year old male and weight was not provided.
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Search Alerts/Recalls
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