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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: defected needle tip, double tipped needle, defected needle bevel.Syringe plunger stuck, jammed during vaccine injection.The plunger stuck and stopped moving forward during vaccine administration, so hcp needs to remove needle from client body and noticed that the needle is defected, it has double tip needle points.Hcp re-administer vaccine injection to client with new syringe and with new calculated vaccine dose.There are many such incidences of plunger stuck/lock occurring in the 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: defected needle tip, double tipped needle, defected needle bevel.Syringe plunger stuck, jammed during vaccine injection.The plunger stuck and stopped moving forward during vaccine administration, so hcp needs to remove needle from client body and noticed that the needle is defected, it has double tip needle points.Hcp re-administer vaccine injection to client with new syringe and with new calculated vaccine dose.There are many such incidences of plunger stuck/lock occurring in the 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 2104421.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, the affected sample was returned for evaluation by our quality engineer team.No issues with plunger movement difficulty were identified with the used sample.Three unused syringes were also returned for evaluation and no issues were detected upon investigation.In regards to the issue of plunger movement difficulty, we would like to inform you that 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.
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Search Alerts/Recalls
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