Catalog Number 309110 |
Device Problem
Manufacturing, Packaging or Shipping Problem (2975)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 06/25/2018 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(6).A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
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Event Description
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It was reported that bd discardit¿ ii syringe was missing marking.No serious injury or medical intervention reported.
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Manufacturer Narrative
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Investigation summary: our manufacturing site was provided with a photo of the product as well as the affected sample.Upon inspection, we could verify the scale marking was missing.We have reviewed our production and inspection records and have established that all production and quality processes were carried out normally.A batch history review showed no non-conformances associated with this issue during the production of this batch.The process we use to print the scale is called "hot stamping system".A metal stamp is heated at around 100ºc.Between the stamp and the barrel, we place a special black printing foil.Using pressure, the stamp pushes the printing foil and its content is embedded in the barrel wall.The result is a black scale printed on the barrel of the syringe.It was determined this issue occurred at the end of this process as a result of a defective foil reel.The reel was not working properly and was not placed between the stamp and barrel, therefore the scale was not printed.Investigation conclusion: the foil reel did not work as expected and was not allocated between the stamp and the barrel, so no scale was printed.
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Event Description
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It was reported that bd discardit¿ ii syringe was missing marking.No serious injury or medical intervention reported.
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Event Description
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It was reported that bd discardit¿ ii syringe was missing marking.No serious injury or medical intervention reported.
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Manufacturer Narrative
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Correction: due to an it issue beginning on 7/3/2018, previously filed emdrs did not contain required fields.This supplemental emdr is filed to provide the following omitted fields: event attributed to: other.Device single use?: no.Device returned to manufacture: yes.
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Search Alerts/Recalls
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