Catalog Number 320440 |
Device Problem
Volume Accuracy Problem (1675)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 05/16/2022 |
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.
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Event Description
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It was reported that while using bd insulin syringes with bd ultra-fine¿ needle experienced syringe scale mark was tilted and blurry.The following information was provided by the initial reporter: that there was the printing of the syringe scale mark was tilted and blurry.
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Event Description
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It was reported that while using bd insulin syringes with bd ultra-fine¿ needle experienced syringe scale mark was tilted and blurry.The following information was provided by the initial reporter: that there was the printing of the syringe scale mark was tilted and blurry.
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Manufacturer Narrative
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H.6.Investigation summary: customer returned 18 loose 0.3ml syringes.The syringes were visually inspected.None of the text or markings on the syringes was found to be illegible.A gauge was used to measure the position of the graduation markings on the syringes.All of the graduation markings were measured within specifications.A review of the device history record was completed for batch # 1074168 all inspections were performed per the applicable operations qc specifications.Based on the samples received, embecta was unable to confirm the customer¿s indicated failure of the scales being misaligned or being light.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored monthly.Our business team regularly reviews the collected data for identification of emerging trends.
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Search Alerts/Recalls
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