Catalog Number 309626 |
Device Problem
Material Puncture/Hole (1504)
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Patient Problem
Needle Stick/Puncture (2462)
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Event Date 11/17/2023 |
Event Type
malfunction
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Manufacturer Narrative
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B.3.The date received by manufacturer has been used for this field.H.3.If a device evaluation and/or device history review is completed, a supplemental report will be filed.
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Event Description
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It was reported that the bd syringe 1ml s/t w/ndl 25x5/8 rb needle went through the shield.The following information was provided by the initial reporter: "while recapping tb syringe needle the needle tip penetrated through the cap wall and into my finger." addition information received by customer on 11/29/2023: "this was not a contaminated needle.It was after medication was drawn but before use with the patient.I do not have the original needle anymore.".
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Manufacturer Narrative
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(b)(4): follow up mdr for device evaluation: one photo was provided.It shows a needle assembly connected to a syringe.The needle assembly has the plastic shield.The needle went through the plastic shield.No other defect or imperfection was observed.Based on the investigation and with the sample analysis the symptom reported by the customer is confirmed.This is off label used.The needle assemblies shouldn't be recapped.A device history record review was completed for provided lot number 0209214 showing no rejected inspections or quality issues during the production of the provided lot number that could have contributed to the reported defect.We appreciate you taking the time to bring this observation to our attention.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored monthly.Our business team regularly reviews the collected data for identification of emerging trends.
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Event Description
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No additional information.
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Search Alerts/Recalls
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