A voluntary recall has been initiated for the bard® marquee® disposable core biopsy instruments and instrument kits which was product catalog/lot number specific.Reportedly the penetration depth switch used to select the desired penetration depth of the biopsy needle for soft tissue biopsies, detaches from the device during use.The penetration depth switch detachments may result in (1) prolongation of the biopsy procedures as the user obtains a replacement device, (2) undershooting the lesion unsuspectedly, compromising the sample quality and potentially leading to a misdiagnosis (3) or if the penetration is overshot, the device may pierce adjacent tissue and/or organs causing injury.To date, there have been no reported patient injuries associated with these penetration depth switch detachments.As a result of the field action, this event is being reported as a malfunction reportable event.The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.The manufacturing location was selected as unknown due to system limitations.The manufacturing location for this product is bd-santo domingo.(expiry date: 03/2023).
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H10: a voluntary recall has been initiated for the bard® marquee® disposable core biopsy instruments and instrument kits which was product catalog/lot number specific.Reportedly the penetration depth switch used to select the desired penetration depth of the biopsy needle for soft tissue biopsies, detaches from the device during use.The penetration depth switch detachments may result in (1) prolongation of the biopsy procedures as the user obtains a replacement device, (2) undershooting the lesion unsuspectedly, compromising the sample quality and potentially leading to a misdiagnosis (3) or if the penetration is overshot, the device may pierce adjacent tissue and/or organs causing injury.To date, there have been no reported patient injuries associated with these penetration depth switch detachments.As a result of the field action, this event is being reported as a malfunction reportable event.H10: the manufacturing location was selected as unknown due to system limitations.The manufacturing location for this product is bd-santo domingo.H10: manufacturing review: the device history records have been reviewed and this lot met all release criteria.There was nothing found within the dhr review to indicate there was a manufacturing related cause for this event.However, gaps within the quality control documents were identified in conjunction with the manufacturing review and will be addressed.Investigation summary: the physical device was not returned for evaluation.No photos were provided for review.However, the investigation is confirmed for the reported break, as the external investigation concluded that the root cause is manufacturing related, as a fixture that assembles this part was missing a pin on one side.This resulted in a gap between the knob and the depth plate/housing that resulted in the reported issue.An external investigation concluded that the root cause is manufacturing related, as a fixture that assembles this part was missing a pin on one side.This resulted in a gap between the knob and the depth plate/housing that resulted in the reported issue.Based upon the available information a definitive root cause could not be determined.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: 03/2023).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 h3 other text : device not returned.
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