GUANGDONG HAIOU MEDICAL APPARATUS CO., LTD. HAIOU NEEDLE RETRACTABLE SAFETY SYRINGE WITH NEEDLE; SYRINGE, ANTISTICK
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Device Problems
Disconnection (1171); Retraction Problem (1536); Material Separation (1562)
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Patient Problem
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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Event Date 03/09/2021 |
Event Type
malfunction
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Event Description
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Covid pfizer treatment under emergency use authorization(eua): on (b)(6) 2021 (b)(6) region team were at (b)(6) giving pfizer vaccines in an outreach event.Some of the needles sent to our team from pfizer to vaccinate were from the guangdong haiou medical apparatus co.Ltd they are a needle retractable safety syringe.Our team lost 1 vaccine because when the vaccine was administered into the clients arm the syringe disconnected from the needle and the vaccine was lost.The client had to be revaccinated.When the team drawing up the vaccines were pulling back the syringe to draw up the vaccine 12 of the syringes came apart and the plunger just came out of the end of the syringe.Nurses who were vaccinating also reported that many of the needles would not properly retract.Our team was able to replace the remaining needles and syringes with needles and syringes we had at our local public health office and we removed the remaining products from the event and have them at our pho and will not use them.That is (b)(6).Fda safety report id# (b)(4).
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