Catalog Number 302632 |
Device Problem
Leak/Splash (1354)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 11/23/2018 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(6).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 with the use of the bd solomed¿ needle there was an issue with medication leakage from stopper of plunger.
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Manufacturer Narrative
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Investigation summary: it was performed the dhr, quality notification and maintenance analysis and no occurrences potentially related to the defect was observed.The sample sent by the customer were verified and it was possible to observe barrel damaged, which caused the leakage during the syringe usage.The potential cause for the occurrence is a jam on assembly machine system, which caused the barrel damage.The incident identified from this complaint will be monitored for trend evaluation.
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Event Description
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It was reported with the use of the bd solomed¿ needle there was an issue with medication leakage from stopper of plunger.
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Search Alerts/Recalls
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