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Model Number 1810MSK |
Device Problem
Device Contamination with Chemical or Other Material (2944)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/01/2021 |
Event Type
malfunction
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Manufacturer Narrative
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As the lot number for the device was provided, a review of the device history records is currently being performed.The return of the sample is pending.The investigation of the reported event is currently underway.(expiry date: 09/2022).
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Event Description
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It was reported that during a biopsy procedure, the device allegedly found foreign material.The procedure was completed by using another device.There was no reported patient contact.
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Manufacturer Narrative
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H10: manufacturing review: the device history records have been reviewed and this lot met all release criteria.There was nothing found to indicate there was a manufacturing related cause for this event.Investigation summary: one mission disposable core biopsy kit was returned for evaluation.During visual evaluation the biopsy instrument appeared to be bloody and was received with protective tubing.Foreign material appeared to be taped to part of the clear plastic packaging.Therefore, the investigation is inconclusive for the reported foreign material issue as device was returned in open condition.A definitive root cause for the reported foreign material could not be determined based upon the provided information.Labeling review: the review of the instructions for use, indications, warnings, precautions, cautions, possible complications, and contraindications showed that the product labeling is adequate.H10: d4 (expiry date: 09/2022), g3.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.
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Event Description
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It was reported that during a biopsy procedure, foreign material was allegedly found on the device.The procedure was completed using another device.There was no patient contact.
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Manufacturer Narrative
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H10: manufacturing review: the device history records have been reviewed and this lot met all release criteria.There was nothing found to indicate there was a manufacturing related cause for this event.Investigation summary: one mission disposable core biopsy kit was returned for evaluation.During visual evaluation the biopsy instrument appeared to be bloody and was received with protective tubing.Foreign material appeared to be taped to part of the clear plastic packaging.Therefore, the investigation is inconclusive for the reported foreign material issue as device was returned in open condition.A definitive root cause for the reported foreign material could not be determined based upon the provided information.Labeling review: the review of the instructions for use, indications, warnings, precautions, cautions, possible complications, and contraindications showed that the product labeling is adequate.H10: d4 (expiry date: 09/2022).
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Event Description
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It was reported that prior to a biopsy procedure, foreign material was allegedly found on the device.The procedure was completed using another device.There was no patient contact.
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Search Alerts/Recalls
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