Catalog Number 300841 |
Device Problem
Mechanical Problem (1384)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 03/24/2019 |
Event Type
malfunction
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Manufacturer Narrative
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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 3 syringes 1ml ls 25ga 5/8in chin graphics had difficult plunger movement during use.The following information was provided by the initial reporter, translated from (b)(6) to english: "it was found the plunger movement difficult during using.There will be a pause when pulling the plunger".
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Manufacturer Narrative
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H.6.Investigation: 8 actual samples in open package and 29 samples in sealed package were returned for investigation.The samples were subjected to plunger breakout and sustaining force test per test procedure 80005457.Result showed breakout and sustaining force is within the product specification.The complaint is unconfirmed, and product is within specification.Review the dhr and no abnormality detected during production.The actual sample and representative sample passed the plunger breakout force and sustaining force test specification.Hence root cause could not be determine.
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Event Description
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It was reported that 3 syringes 1ml ls 25ga 5/8in chin graphics had difficult plunger movement during use.The following information was provided by the initial reporter, translated from chinese to english: "it was found the plunger movement difficult during using.There will be a pause when pulling the plunger".
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Search Alerts/Recalls
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