Catalog Number 309623 |
Device Problems
Leak/Splash (1354); Difficult to Remove (1528); Material Separation (1562)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 02/26/2019 |
Event Type
malfunction
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Manufacturer Narrative
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Date of event: unknown.The date received by manufacturer has been used for this field.Device expiration date: unknown.Device manufacture date: unknown.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 a bd 1ml tb syringe slip tip had leakage.The following was reported, "consumer reported needle hub separated when pulling off shield.Also mentioned, when she re-attached the hub on one syringe, the medication leaked out.Stated shields are hard to remove.5 syringes affected.Occurrence dates unknown.Lot: unknown, item: 309623, no expiration date.Samples available.Per consumers request, sending item: 328411 as replacement.".
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Manufacturer Narrative
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Investigation: sixteen 1ml syringes with needles (p/n 309623) were received and visually inspected.Thirteen were in fully sealed blister packs with twelve confirmed to be from batch #4119922 and one confirmed to be from batch #8213898.Three were in opened blister from batch #8213898.One of the shields from a syringe in an opened blister pack was observed to have small cracks where the hub contacts the shield.Furthermore, a device history record review showed no rejected inspections or quality issues during the production of the provided lot number that could have contributed to the reported defect.A shield removal force test was performed on all unopened samples using a force gage.No defects were observed.Root cause not defined since defects were not confirmed in the samples received.
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Event Description
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It was reported that a bd 1ml tb syringe slip tip had leakage.The following was reported, "consumer reported needle hub separated when pulling off shield.Also mentioned, when she re-attached the hub on one syringe, the medication leaked out.Stated shields are hard to remove.5 syringes affected.Occurrence dates unknown.Lot: unknown, item: 309623, no expiration date.Samples available.Per consumers request, sending item: 328411 as replacement.".
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Search Alerts/Recalls
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