Catalog Number 324907 |
Device Problem
Difficult or Delayed Positioning (1157)
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Patient Problem
Skin Tears (2516)
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Event Date 11/06/2023 |
Event Type
malfunction
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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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Event Description
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It was reported that while using the bd ultra-fine¿ insulin syringe deep lacerations were left below needle puncture site.Report 2 of 2.The following was received by the initial reporter: consumer reported found 2 syringes that hurt and tore up skin when removed.This caller informed he reuses - each syringe used for 2 injections.Informed caller not to reuse.With reasons.Date of event 11/06/2023 = 1 syringe - awaiting sample date of event 11/05/2023 - 1 syringe -discard.
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Event Description
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It was reported that while using the bd ultra-fine¿ insulin syringe deep lacerations were left below needle puncture site.Report 1 of 2.The following was received by the initial reporter: consumer reported found 2 syringes that hurt and tore up skin when removed.This caller informed he reuses - each syringe used for 2 injections.Informed caller not to reuse.With reasons.Date of event (b)(6) 2023 = 1 syringe - awaiting sample date of event (b)(6) 2023 - 1 syringe -discard.
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Manufacturer Narrative
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The following fields have been updated due to additional information: b.5.Correction: report 9319541 is report 1 of 2, not report 2 of 2.D.9.Device available for eval?: yes.D.9.Returned to manufacturer on: (b)(6) 2024.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 and based on trend analysis no further action is required at this time.Complaints received for this device and reported condition will continue to be tracked and trended.Based on the above, no additional investigation and corrective/preventative action (capa) or situational analysis (sa) is required.
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Search Alerts/Recalls
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