Catalog Number 300195 |
Device Problem
Device Misassembled During Manufacturing /Shipping (2912)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 11/06/2019 |
Event Type
malfunction
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Manufacturer Narrative
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The manufacturing location for this product is (b)(4).This site is an oem manufacturing site.Therefore, bd corporate headquarters in (b)(4) has been listed and the (b)(4) fda registration number has been used for the manufacture report number.Medical device expiration date: 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 has been reported that one sharps coll asia 13.2l yel 1508 non-vent has been found with a broken lid before use.The following has been provided by the initial reporter: broken sharp cover.We received feedback on the quality issue on the 13.2l sharp container.Users detected that lid for the sharp container has broken, it will cause potential harm to users as well as to the public since the lid cannot be locked.Item details: material code: 1306-01-009-a.Material description: container contaminated sharp 13.2l.Product code: 300195.Batch no.: 8274903.Affected quantity: 1 pc.
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Event Description
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It has been reported that one sharps coll asia 13.2l yel 1508 non-vent has been found with a broken lid before use.The following has been provided by the initial reporter: broken sharp cover we received feedback on the quality issue on the 13.2l sharp container.Users detected that lid for the sharp container has broken, it will cause potential harm to users as well as to the public since the lid cannot be locked item details: material code: 1306-01-009-a, material description: container contaminated sharp 13.2l, product code: 300195, batch no.8274903, affected quantity: 1 pc.
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Manufacturer Narrative
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H.6.Investigation: a sample picture was provided for the issue and a compliant review was performed by the manufacturer.An investigation was completed for the issue of lid broken and cannot be locked.A dhr review and nonconformance review showed there were no issues observed for lid broken.Based on the sample the cap of the lid was detached from the hinge, there are stress marks at both sides of the hinge, and the rupture of the hinge was not uniform.According with this investigation the failure mode appears to be caused by a molding issue during the manufacturing process.The process mold will be updated to provide greater hinge support to avoid breaking.H3 other text : see h.10.
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Search Alerts/Recalls
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