Catalog Number 309657 |
Device Problems
Leak/Splash (1354); Material Separation (1562)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 05/05/2022 |
Event Type
malfunction
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Event Description
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It was reported that at least 2 bd 60ml syringes luer-lok¿ tip were unable to connect to their mating components, resulting in leakage.The following information was provided by the initial reporter: medication syringes leaking during administration at the site of the syringe leur lock tip.Certain bd 3 ml syringes will consistently result in leakage during administration.
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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.There were multiple lot numbers reported to be involved.The information for each lot number is as follows: medical device lot #: 1131286.Medical device expiration date: 31-may-2026.Device manufacture date: 28-june-2021.Medical device lot #: 1196125.Medical device expiration date: 31-july-2026.Device manufacture date: 09-sept.-2021.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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Manufacturer Narrative
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H6: investigation summary one 3ml syringe sample with no lot number identified received by our quality team for investigation.Upon visual inspection, the luer appears damaged.Leakage test was performed, leak occurred with the max zero device.The provided sample was manufactured in the m-143 mold, and corresponds to cavity 44, it has been detected that mold 143 has some cavities that present a damaged luer, so they are considered as part of the action plan.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.Possible root cause is associated with the molding process.Failure in the mold temperature and injection process.Actions include updating production log to include the leak test with the help of the max zero device.
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Event Description
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It was reported that at least 2 bd 60ml syringes luer-lok¿ tip were unable to connect to their mating components, resulting in leakage.The following information was provided by the initial reporter: medication syringes leaking during administration at the site of the syringe leur lock tip.Certain bd 3 ml syringes will consistently result in leakage during administration.
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Search Alerts/Recalls
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