Catalog Number 47451130 |
Device Problems
Break (1069); Difficult or Delayed Activation (2577)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/19/2021 |
Event Type
malfunction
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Manufacturer Narrative
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Investigation summary: the customer issued a complaint for a detached syringe detected by end user.Photos were provided to bd medical ¿ pharmaceutical system (bdm-ps) for analysis.Bdm-ps performed a batch history record¿s review (bhr) including a review of all data collected during in process and quality inspections.The batches involved in this complaint meet all acceptable quality levels (aql¿s), were manufactured and released according to applicable procedures and specifications.Based on investigation conclusion a syringe can only become detached if syringe capture features or the flange of the syringe get damaged/broken or if the syringe receives an impact after syringe insertion which causes it to unclip from the device.Therefore, the syringe most likely became detached as it was not clipped into the device properly or it received an external impact after syringe insertion which caused it to unclip from the device.None of these causes are related to bd process.
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Event Description
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It was reported that a ultrasafe plus x100l png clear had a broken safety device before use.The following was reported by the initial reporter: "after opening the package it was discovered that the syringe is defective.The needle shield cap is partially inside the spring.The glass medicine vial can move in and out of the safety device.The syringe was not used.".
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Manufacturer Narrative
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The following fields were updated due to additional information: d.10.Device available for eval?: yes.D.10.Returned to manufacturer on: 4/16/2021.H.6.Investigation: the customer issued a complaint for a detached syringe detected by end user.Photos and 1 sample were provided to bd medical ¿ pharmaceutical system (bdm-ps) for analysis.Bdm-ps performed a batch history record¿s review (bhr) including a review of all data collected during in process and quality inspections.The batches involved in this complaint meet all acceptable quality levels (aql¿s), were manufactured and released according to applicable procedures and specifications.Based on investigation conclusion a syringe can only become detached if syringe capture features or the flange of the syringe get damaged/broken or if the syringe receives an impact after syringe insertion which causes it to unclip from the device.Therefore, the syringe most likely became detached as it was not clipped into the device properly or it received an external impact after syringe insertion which caused it to unclip from the device.None of these causes are related to bd process.
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Event Description
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It was reported that a ultrasafe plus x100l png clear had a broken safety device before use.The following was reported by the initial reporter: "after opening the package it was discovered that the syringe is defective.The needle shield cap is partially inside the spring.The glass medicine vial can move in and out of the safety device.The syringe was not used.".
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Search Alerts/Recalls
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