BECTON DICKINSON, S.A. BD PHASEAL ¿ INJECTOR LURE LOCK N35J; INTRAVASCULAR ADMINISTRATION SET
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Catalog Number 515008 |
Device Problem
Contamination (1120)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 04/18/2022 |
Event Type
malfunction
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Manufacturer Narrative
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A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.
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Event Description
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It was reported while using bd phaseal ¿ injector lure lock n35j coring led to foreign matter in the fluid path.There was no report of patient impact.The following information was provided by the initial reporter: according to the customer¿s report, during preparation of the anticancer agent alimta using p120j and n35j connected to a syringe, coring occurred.
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Manufacturer Narrative
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The following fields were updated due to additional information: d10: device available for eval yes.D10: returned to manufacturer on: 11-sep-2022.H6: investigation summary: multiple samples were provided to our quality team for investigation.The product was visually inspected, no defects or damage observed on the protector or injector cannulas or membranes, the protectors fit securely to the vial, the needle on the protector penetrated the vial stopper properly.During our evaluation, a black particle was observed from inside several of the vials.Characterization testing was requested but could not be performed at this time, therefore the composition and origin of the particle could not be determined.A device history review was performed for protector lot 2104123 and injector lot 2105004, no deviations or non-conformances were identified during the manufacturing process that could have contributed to these issues.
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Event Description
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It was reported while using bd phaseal ¿ injector lure lock n35j coring led to foreign matter in the fluid path.There was no report of patient impact.The following information was provided by the initial reporter: according to the customer¿s report, during preparation of the anticancer agent alimta using p120j and n35j connected to a syringe, coring occurred.
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