Catalog Number 305181 |
Device Problem
Contamination (1120)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 09/06/2023 |
Event Type
malfunction
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Event Description
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It was reported that the bd¿ blunt fill needle with syringe caused visible coring in 7 daptomycin vials.The following information was provided by the initial reporter: "today we did a small trial using the bd blunt fill needles (18g x 1 inch ref (b)(4); lot 3086627 exp 5/31/2028).I reviewed the appropriate technique with our pharmacy technician.She then reconstituted 20 vials of daptomycin using them.Of the 20 vials we saw visible cores in 5 of them.None were sent out to patients.We also withdrew doses from several other daptomycin vials that had been reconstituted the previous day and were stored in the fridge.None of the vials contained a visible core.However when we used the blunt fill needles to withdraw doses we had visible cores in 7 of the final dose syringes.We then filtered them so we could use the medication.At this point the blunt fill needles don쳌t seem to be working to prevent coring of these vials.".
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Manufacturer Narrative
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H.3.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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Manufacturer Narrative
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H6: investigation summary a device history record review was completed by our quality engineer team for provided material number 305181 and lot number 3086627.The review did not reveal any detected abnormalities during the production process that could have contributed to this defect and all quality tests were found to be within specification.As a sample was unavailable for return, a thorough sample investigation could not be completed.Based on the investigation results, an exact cause for this incident could not be identified.H3 other text : see h10.
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Event Description
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It was reported that the bd¿ blunt fill needle with syringe caused visible coring in 7 daptomycin vials.The following information was provided by the initial reporter: "today we did a small trial using the bd blunt fill needles (18g x 1 inch ref (b)(4); lot 3086627 exp 5/31/28).I reviewed the appropriate technique with our pharmacy technician.She then reconstituted 20 vials of daptomycin using them.Of the 20 vials we saw visible cores in 5 of them.None were sent out to patients.We also withdrew doses from several other daptomycin vials that had been reconstituted the previous day and were stored in the fridge.None of the vials contained a visible core.However when we used the blunt fill needles to withdraw doses we had visible cores in 7 of the final dose syringes.We then filtered them so we could use the medication.At this point the blunt fill needles don쳌t seem to be working to prevent coring of these vials.".
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Search Alerts/Recalls
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