It was reported that 2 bd veo insulin syringes experienced product damage while still considered operable. the following information was provided by the initial reporter: consumer reported, finding one syringe with a damaged barrel.Stated, "flanges" were broken off prior to injection.
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H6: investigation summary customer returned (1) loose 0.3ml bd insulin syringe.The consumer reported finding one syringe with a damaged barrel, and stated that the "flanges" were broken off prior to injection.The returned syringe was examined, and it was observed that the plunger rod was broken at the thumb press.No damage to the plunger cap, flange, or barrel was observed.A review of the device history record was completed for batch# 1123291.All inspections and challenges were performed per the applicable operations qc specifications.There were zero (0) notifications noted that pertained to the complaint bd was able to confirm the customer¿s indicated failure (plunger rod broken).Root cause: maintenance dispatch (l2l) was reviewed, and 1 dispatch was opened for plunger jams / not feeding down the rail.The plungers are guided down a rail by the plunger head.When a jam occurs, the plungers are removed however it the jam is minor and dissipates on its own, it may have weakened the plunger head prior to assembling the syringe.H3 other text : see h10.
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It was reported that 2 bd veo insulin syringes experienced product damage while still considered operable. the following information was provided by the initial reporter: consumer reported, finding one syringe with a damaged barrel.Stated, "flanges" were broken off prior to injection.
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