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Catalog Number 306398 |
Device Problem
Failure to Deliver (2338)
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Patient Problem
Pain (1994)
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Event Date 08/17/2021 |
Event Type
malfunction
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Manufacturer Narrative
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A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.
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Event Description
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It was reported that syringe soloshot mini 0.3ml 23x1 plunger was difficult to move.The following information was provided by the initial reporter: syringe plunger stuck during vaccine administration to client.Plunger stopped half way during injection procedure, not moving even with hard push, it get jammed and get bent.There are multiple such incidences taking place on daily basis in this vaccine center.Patient impact: the vaccine recipient/client complains very painful injection.The syringe plunger stuck half way during vaccine dose administration in recipient body.Hcp needs to terminate vaccine injection procedure.Hcp re-administer vaccine to client.Client received two injection shots.
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Event Description
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It was reported that syringe soloshot mini 0.3ml 23x1 plunger was difficult to move.The following information was provided by the initial reporter: syringe plunger stuck during vaccine administration to client.Plunger stopped half way during injection procedure, not moving even with hard push, it get jammed and get bent.There are multiple such incidences taking place on daily basis in this vaccine center.Patient impact: the vaccine recipient/client complains very painful injection, the syringe plunger stuck half way during vaccine dose administration in recipient body, hcp needs to terminate vaccine injection procedure.Hcp re-administer vaccine to client.Client received two injection shots.
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Manufacturer Narrative
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H.6.Investigation: a device history record review was completed for provided lot number 2104424.The review did not reveal any detected abnormalities during the production process that could have contributed to the reported defect and all quality tests were found to be within specification.To aid in the investigation of this issue, four used physical samples were returned for evaluation by our quality engineer team.The samples had medication in the fluid path and the clips were already activated.Since the clip was already activated, the plunger may go up, but it cannot go down.Four unused samples were also provided.The four unused samples displayed no signs of defect.The bd soloshot mini syringes are single use devices.The auto-disable two-piece syringe consists of two plastic parts and a metallic clip.The function of this clip is to avoid reuse of the syringe to prevent infection transmission.Once the clip is activated, the syringe plunger will not depress.The syringe should be totally closed before drawing up medication.H3 other text : see h.10.
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Search Alerts/Recalls
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