Catalog Number 1251CSF1 |
Device Problem
Physical Resistance/Sticking (4012)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/13/2022 |
Event Type
malfunction
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Manufacturer Narrative
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As the lot number for the device was not provided, a review of the device history record could not be performed.The device has been returned to the manufacturer for evaluation.The investigation of the reported event is currently underway.
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Event Description
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It was reported that during a brachytherapy procedure, the last two seeds of the device allegedly could not be discharged from the loader.It was further reported that one of the seeds were ejected by pushing the plunger but seed from the other cartridge failed to eject.The last seed was removed from applicator by flipping and shaking the plunger.There was no reported patient injury.
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Event Description
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It was reported that during a brachytherapy procedure, the last two seeds of the device allegedly could not be discharged from the loader.It was further reported that one of the seeds were ejected by pushing the plunger but seed from the other cartridge failed to eject.The last seed was removed from applicator by flipping and shaking the plunger.There was no reported patient injury.
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Manufacturer Narrative
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H10: the initial mdr was inadvertently submitted with a g3 date of 17-feb-2022.The correct g3 date is 13-jan-2022.H10: manufacturing review: a device history record review was performed for the affected lot numbers of the seeds, source caps and the lot number of the cartridge.No issues were noted.Investigation summary: one modified mick-15 cartridges was returned for evaluation and was labeled as biohazardous.The cartridge was inspected and nothing unusual was noted on the outside.The modified mick -15 cartridge was loaded with 15 non-radioactive brachyseeds / sourcecaps and was inserted into a mick applicator.All 15 non-radioactive brachyseeds / sourcecaps from the cartrdige dispensed as expected.Upon completion of dispensing, the cartridge was removed from the applicator and examined.Nothing unusual was noted.The investigation is unconfirmed for the reported issue.A definite root cause could not determined based upon the available information.Labeling review: labeling was reviewed and found to be adequate.There is a warning section stating how to handle the magazine when loaded with seeds as well as warning of over tightening the magazine head to the base.H10: g3 h11: h6(result, conclusion) 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.H3 other text : see h10.
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Search Alerts/Recalls
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