Catalog Number 328322 |
Device Problem
Delivered as Unsterile Product (1421)
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Patient Problem
Needle Stick/Puncture (2462)
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Event Date 03/17/2021 |
Event Type
malfunction
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Manufacturer Narrative
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Initial reporter phone#: (b)(6).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 syringe 0.3ml 30ga 8mm 10bag 500 l amr needle penetrated the shield.The following information was provided by the initial reporter: customer informs that she purchased a package of bd ultra-fine 8mm syringes in the capacity of 30ui (lot: 6228801 c manufacture: 09/2016 validity: 08/2021) and ended up accidentally puncturing with the syringe.She mentions that the needle was transfixed in the orange protective cover and punctured the package, which was sealed.There was no bruise on the spot.The customer also informed, by e-mail, the following: "i bought a bd ultra fine ll insulin syringe package with 10 units, when i took it out of the bag i was pricked by a needle that is bent inside the syringe, i did not open a package, the pharmacy does not exchange because it is a factory defect.I would like to make a direct exchange with the supplier.".
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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.A review of the manufacturing records was performed, and no non-conformances were raised in association with this type of event for this lot.A review of the device history record was completed for batch#: 6228801.All inspections were performed per the applicable operations qc specifications.There were zero (0) notifications noted that pertained to the complaint.
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Event Description
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It was reported that syringe 0.3ml 30ga 8mm 10bag 500 l amr needle penetrated the shield.The following information was provided by the initial reporter: customer informs that she purchased a package of bd ultra-fine 8mm syringes in the capacity of 30ui (lot: 6228801 c manufacture: 09/2016 validity: 08/2021) and ended up accidentally puncturing with the syringe.She mentions that the needle was transfixed in the orange protective cover and punctured the package, which was sealed.There was no bruise on the spot.The customer also informed, by e-mail, the following: "i bought a bd ultra fine ll insulin syringe package with 10 units, when i took it out of the bag i was pricked by a needle that is bent inside the syringe, i did not open a package, the pharmacy does not exchange because it is a factory defect.I would like to make a direct exchange with the supplier ".
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Search Alerts/Recalls
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