BARD BRACHYTHERAPY, INC. -1424526 I125 SEEDS IN QUICKLINK CARTRIDGE SINGLE, STERILE; BRACHYTHERAPY LINKS & CARTRIDGES
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Catalog Number 1251QCS |
Device Problem
Component Misassembled (4004)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/22/2024 |
Event Type
malfunction
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Event Description
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It was reported that during a brachytherapy procedure, the cartridge counters were allegedly inaccurate as there were allegedly eleven seeds in a cartridge which was supposed to have only ten seeds.There was no patient contact.
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Manufacturer Narrative
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H10: as the lot number for the device was not provided, a review of the device history records could not be performed.The return of the sample is pending.The investigation of the reported event is currently underway.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 : device pending return.
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Manufacturer Narrative
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H10: additional information was received, the file was reassessed for reportability and determined to be no longer reportable.Since an initial mdr was submitted, therefore, the file will remain assessed as a malfunction.H10: g3 h11: b5 h11: section a through f ¿ the information provided 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 pending return.
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Event Description
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It was reported that prior to a brachytherapy procedure, the cartridge counters were allegedly inaccurate as there were allegedly eleven seeds in a cartridge which was supposed to have only ten seeds.There was no patient contact.
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Search Alerts/Recalls
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