Model Number 324910 |
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 05/11/2022 |
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 the bd veo¿ insulin syringes with bd ultra-fine¿ needle 3/10ml 6mm zero point scale mark is lower than it should be and more insulin was drawn.The following information was provided by the initial reporter: the zero point scale mark is lower than it should be.Therefore, more insulin is drawn.
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Event Description
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It was reported that the bd veo¿ insulin syringes with bd ultra-fine¿ needle 3/10ml 6mm zero point scale mark is lower than it should be and more insulin was drawn.The following information was provided by the initial reporter: the zero point scale mark is lower than it should be.Therefore, more insulin is drawn.
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Manufacturer Narrative
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The following fields were updated due to additional information: d.9 device available for eval: yes.D.9 returned to manufacturer on: 20-may-2022.H.6 investigation summary: samples were received and an investigation was performed.This is the 1st complaint for the reported lot number.A review of the manufacturing records was performed and no non-conformances were raised in association with this type of event for this lot.Embecta was not able to duplicate or confirm the indicated issue.Hence a potential root cause cannot be determined.Complaints received for this device and reported condition will continue to be tracked and trended.Customer returned (3) 0.3ml syringes.The syringes were visually inspected and measured using a gauge.The graduation markings on the side of the syringe barrel appear printed lower than average.However, the measurement gauge shows that the markings at the 5 and 30 unit marks are still within specification.Based on the above, no additional investigation and no corrective/preventative action (capa) or situational analysis (sa) is required at this time.
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Search Alerts/Recalls
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