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Model Number MQ1410 |
Device Problem
Break (1069)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/18/2020 |
Event Type
malfunction
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Manufacturer Narrative
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As the lot number for the device was provided, a manufacturing review will be performed.The sample was not returned to the manufacturer for inspection/evaluation.Therefore, the investigation of the reported event is inconclusive.Based upon the available information, the definitive root cause for this event is unknown.The instructions for use (ifu) is adequate for the reported device/patient code(s) and provides general instructions for use, as well as warnings, precautions and potential complications associated with the device.Upon receipt of new or additional information, a follow-up report will be submitted as applicable.(expiry date: 05/2023).
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Event Description
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It was reported that during a biopsy, the needle allegedly broke.The procedure was completed using another device.There was no reported patient injury.
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Event Description
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It was reported that during a biopsy, the switch allegedly broke externally.The procedure was completed using another device.There was no reported patient injury.
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Manufacturer Narrative
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H10: the file was reassessed for reportability and determined to be no longer reportable.H10: the manufacturing site was selected as unknown due to system limitations.The manufacturing site for this product is bd sant domingo.H10: as the lot number for the device was provided, a manufacturing review will be performed.The sample was not returned to the manufacturer for inspection/evaluation.Therefore, the investigation of the reported event is inconclusive.Based upon the available information, the definitive root cause for this event is unknown.The instructions for use (ifu) is adequate for the reported device/patient code(s) and provides general instructions for use, as well as warnings, precautions and potential complications associated with the device.Upon receipt of new or additional information, a follow-up report will be submitted as applicable.H10: d4 (expiry date: 05/2023),g4 h11: b3,b5 h11: section a through f ¿ the information provide by bd represents all 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.Device not returned.
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Search Alerts/Recalls
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