Model Number 309653 |
Device Problem
Device Markings/Labelling Problem (2911)
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Patient Problem
No Patient Involvement (2645)
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Event Date 05/14/2020 |
Event Type
malfunction
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Manufacturer Narrative
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Date of event: unknown.The date received by manufacturer has been used for this field.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.(b)(4).
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Event Description
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It was reported that the shipping boxes of bd syringes with the luer-lok¿ tip had the volume listed as "50 ml" instead of "60 ml".This was noticed prior to use.The following information was provided by the initial reporter: "all stickers on the shipping boxes have the correct art.Number, however on 5 boxes out of 6 the volume of the syringes is stated as 50 ml instead of 60 ml.The real volume corresponds to the sticker.Only 1 box arrived with the correct sticker and volume of syringes.".
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Manufacturer Narrative
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Investigation summary: four photos were provided for evaluation.They show a packaging box label with 50ml.Also, packaging blisters as well as two syringes, one 60ml and one 50ml; both samples have the correct packaging top web blister identification.From the photos, we can conclude that the customer has a box(es) labeled 60ml with product 60ml lot# 9120907.The customer also has a box(es) labeled 50ml with 50ml syringes.The lot# starts as 00075??? the rest of the digits are not clearly visible in the photo.Anyway.This lot# starting with those digits were created during this year.This means that these two lots were produced with a one-year difference.Based on the investigation and with the photo provided, the symptom reported by the customer is confirmed.We conclude that at a certain point in the supply chain boxes with 50ml and 60ml syringe boxes were put together.The manufacturing site is ruled out as a source of the symptoms reported since these lots were produced over a year apart from each other.It is unknown where it could have happened.
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Event Description
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It was reported that the shipping boxes of bd syringes with the luer-lok¿ tip had the volume listed as "50 ml" instead of "60 ml".This was noticed prior to use.The following information was provided by the initial reporter: "all stickers on the shipping boxes have the correct art.Number, however on 5 boxes out of 6 the volume of the syringes is stated as 50 ml instead of 60 ml.The real volume corresponds to the sticker.Only 1 box arrived with the correct sticker and volume of syringes.".
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Search Alerts/Recalls
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