Catalog Number 328322 |
Device Problem
Material Puncture/Hole (1504)
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Patient Problem
Needle Stick/Puncture (2462)
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Event Date 02/09/2021 |
Event Type
malfunction
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Manufacturer Narrative
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Date of event: unknown.A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.
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Event Description
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It was reported that a syringe 0.3ml 30ga 8mm 10bag 500 l amr had the needle cannula through the needle shield in the polybag before use.The following was reported by the initial reporter: "pharmaceutical manager contacted us informing a quality deviation in the bd ultra-fine 8mm needles capacity 30ui, informed that they acquired the syringes from the distributor and when the attendant was launching the product in the system, it was punctured with the needle of the syringe that was crossed in the cover protective.In the form sent it is informed that there was an accidental prick with the needle, but there was no medical or surgical intervention, only performed asepsis at the puncture site.".
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Event Description
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It was reported that a syringe 0.3ml 30ga 8mm 10bag 500 l amr had the needle cannula through the needle shield in the polybag before use.The following was reported by the initial reporter: "pharmaceutical manager contacted us informing a quality deviation in the bd ultra-fine 8mm needles capacity 30ui, informed that they acquired the syringes from the distributor and when the attendant was launching the product in the system, it was punctured with the needle of the syringe that was crossed in the cover protective.In the form sent it is informed that there was an accidental prick with the needle, but there was no medical or surgical intervention, only performed asepsis at the puncture site.".
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Manufacturer Narrative
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H6: investigation summary: customer returned two images of a pouch labeled for 0.3ml, 30 gauge, 8mm syringes from lot 9077904.The pouch does not appear to have been opened.Inside the pouch is a syringe with the needle sticking out the side of the needle shield at an angle.A review of the device history record was completed for batch # 9077904 all inspections were performed per the applicable operations qc specifications.There was one (1) notification noted that did not pertain to the complaint.Root cause cannot be determined.Based on the images received, bd was able to confirm the customer¿s indicated failure of the needle shield being pierced by the needle cannula, potentially resulting in a needle stick.H3 other text : see h10.
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Search Alerts/Recalls
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