Model Number 305945 |
Device Problems
Leak/Splash (1354); Retraction Problem (1536)
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Patient Problem
Exposure to Body Fluids (1745)
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Event Date 07/02/2020 |
Event Type
Injury
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Manufacturer Narrative
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(b)(6).A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.(b)(4).
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Event Description
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It was reported that the syringe sftygld 1ml w/ndl 27x1/2 rb experienced a broken safety mechanism, blood exposure -splash, and a post use dirty needle stick injury.Product defects were noted after use.It has not been specified whether any medical intervention was received as a result of the needle stick injury.The following information was provided by the initial reporter: material no: 305945 batch no: 6131957.Safety glide needle cover deployed after tb skin test performed.Able to unlock safetyglide cover which slid back and resulted in a needlestick injury.
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Event Description
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It was reported that the syringe sftygld 1ml w/ndl 27x1/2 rb experienced a broken safety mechanism, blood exposure-splash, and a post use dirty needle stick injury.Product defects were noted after use.It has not been specified whether any medical intervention was received as a result of the needle stick injury.The following information was provided by the initial reporter: material no: 305945.Batch no: 6131957.Safety glide needle cover deployed after tb skin test performed.Able to unlock safetyglide cover which slid back and resulted in a needlestick injury.
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Manufacturer Narrative
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Investigation summary: no samples (including photos) were returned therefore the complaint could not be confirmed and the root cause is undetermined.Complaints received for this device and reported condition will continue to be tracked and trended.If samples are received in the future the complaint will be reopened for further investigation.A review of the device history record was completed for batch# 6131957.All inspections and challenges were performed per the applicable operations qc specifications.There were zero (0) notifications noted that pertained to the complaint.
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Search Alerts/Recalls
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