Catalog Number 304086 |
Device Problems
Leak/Splash (1354); Obstruction of Flow (2423)
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Patient Problem
No Information (3190)
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Event Date 12/24/2018 |
Event Type
malfunction
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Manufacturer Narrative
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Multiple lot numbers: there were multiple lot numbers reported to be involved.The information for each lot number is as follows: medical device lot #: 8057936.Medical device expiration date: n/a.Device manufacture date: 2018-02-26.Medical device lot #: 8025585.Medical device expiration date: n/a.Device manufacture date: 2018-01-25.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 two bd¿ syringe 10cc s/t wos sterile water bns had plastic debris of plunger were stuck between the plunger tip and inner wall of the barrel, resulted in leakage, which leaded to no water inside syringe upon opening the package.
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Event Description
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It was reported that two bd¿ syringe 10cc s/t wos sterile water bns had plastic debris of plunger were stuck between the plunger tip and inner wall of the barrel, resulted in leakage, which leaded to no water inside syringe upon opening the package.
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Manufacturer Narrative
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Investigation: since no samples displaying the condition reported are available for examination, we were unable to fully investigate this incident.A device history record review showed no rejected inspections or quality issues during the production of the two provided lot number(s) that could have contributed to the reported defect.The reported issue was previously investigated.After exhaustive review of the assembly process, it was concluded that the damage found in the barrel was caused due to improper setup of the silicone gun used to spray medical grade silicone inside the barrel.If the silicone gun is setup loose, it could contact and damage the barrel during processing.
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Search Alerts/Recalls
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