Catalog Number 324826 |
Device Problem
Separation Problem (4043)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/13/2023 |
Event Type
malfunction
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Manufacturer Narrative
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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 plunger pulled out of the bd micro-fine¿+ demi insulin syringe when attempting to remove the cap.The following information was provided by the initial reporter, translated from german: "when the customer pulls off the lower cap, not only does the cap come off, but she also pulls out the plunger of the syringe.".
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Manufacturer Narrative
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H6: investigation summary; no samples were returned therefore the investigation was performed based on the photos provided.The customer returned two photos of the 30gx8mm bd syringes.The customer reported that when the lower cap is pulled off, not only does the cap come off, but she also pulls out the plunger of the syringe.Furthermore, the cap is firmly connected to the syringe plunger, but cannot be released.The photo was observed, and displays a single syringe without any packaging, lying flat and dismantled with the plunger rod lying next to the barrel with the cap still attached.A review of the device history record was completed for batch# 2045463.All inspections and challenges were performed per the applicable operations qc specifications.Embecta was able to duplicate or confirm the customer¿s indicated failure based on the photo received.The root-cause could not be determined.H3 other text : see h10.
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Event Description
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It was reported that the plunger pulled out of the bd micro-fine¿+ demi insulin syringe when attempting to remove the cap.The following information was provided by the initial reporter, translated from german: "when the customer pulls off the lower cap, not only does the cap come off, but she also pulls out the plunger of the syringe.".
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Search Alerts/Recalls
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