Model Number 328418 |
Device Problem
Failure to Deliver (2338)
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Patient Problem
Needle Stick/Puncture (2462)
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Event Date 12/01/2019 |
Event Type
malfunction
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Manufacturer Narrative
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A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
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Event Description
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It was reported that the bd insulin syringe with the bd ultra-fine¿ needle was "2 to 3 inches" in length and sticking out from the side of the barrel; the consumer did not notice this and stuck their finger on it while drawing up insulin during use.The following information was provided by the initial reporter: "consumer called in to report, she stuck her middle right finger with needle from syringe stated, when she removed the syringe from the bag, and started to draw up her insulin, she stuck her finger on a needle sticking out from side of barrel.Stated, the needle was 2 to 3 inches in length.Stated, she didn't notice the needle sticking out from barrel before she started to draw insulin administered some first aid at home.Does not plan on seeking medical".
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Event Description
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It was reported that the bd insulin syringe with the bd ultra-fine¿ needle was "2 to 3 inches" in length and sticking out from the side of the barrel; the consumer did not notice this and stuck their finger on it while drawing up insulin during use.The following information was provided by the initial reporter: "consumer called in to report, she stuck her middle right finger with needle from syringe stated, when she removed the syringe from the bag, and started to draw up her insulin, she stuck her finger on a needle sticking out from side of barrel.Stated, the needle was 2 to 3 inches in length.Stated, she didn't notice the needle sticking out from barrel before she started to draw insulin administered some first aid at home.Does not plan on seeking medical".
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Manufacturer Narrative
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H.6.Investigation: no samples (including photos) were returned as of(b)(6)2020 therefore the complaint could not be confirmed and the root cause is undetermined.A review of the device history record was completed for batch# 8115511.All inspections were performed per the applicable operations qc specifications.There was one (1) notification [200753438] noted for fm on outer diameter of cannula.H3 other text : see h.10.
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Manufacturer Narrative
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H.6.Investigation: customer returned photos of a 1cc syringe.Customer states that she experienced a needle stick while drawing up her insulin from a needle sticking out of the side of the barrel.The attached photos were examined and exhibited a cannula exposed on the side of the barrel which could lead to a needle stick.A review of the device history record was completed for batch# 8115511.All inspections were performed per the applicable operations qc specifications.There was one (1) notification [200753438] noted for fm on outer diameter of cannula.There were no quality notifications or maintenance dispatches during the manufacture time period of this batch, that pertained to the complaint.Therefore, no root cause can be determined.H3 other text : see h.10.
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Event Description
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It was reported that the bd insulin syringe with the bd ultra-fine¿ needle was "2 to 3 inches" in length and sticking out from the side of the barrel; the consumer did not notice this and stuck their finger on it while drawing up insulin during use.The following information was provided by the initial reporter: "consumer called in to report, she stuck her middle right finger with needle from syringe stated, when she removed the syringe from the bag, and started to draw up her insulin, she stuck her finger on a needle sticking out from side of barrel.Stated, the needle was 2 to 3 inches in length.Stated, she did not notice the needle sticking out from barrel before she started to draw insulin administered some first aid at home.Does not plan on seeking medical.".
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Search Alerts/Recalls
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