Catalog Number 301031 |
Device Problems
Break (1069); Volume Accuracy Problem (1675); Device Contamination with Chemical or Other Material (2944)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 09/21/2021 |
Event Type
malfunction
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Manufacturer Narrative
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Investigation summary: it was reported there were black dots, bad impressions and damaged, or broken pieces.To aid in the investigation, ten samples and four photos were received for evaluation by our quality team.A visual inspection was performed with a 10x magnifier lens.Seven samples have embedded degraded resin, one sample has barrel damage, one sample has a barrel printing issue and one sample was found with no defects or imperfections observed.The four photos provided show some of the samples received.The embedded degraded resin in the component typically occurs at the startup or intermittently during the injection molding process.The degraded resin can break loose and be molded into components.For the damaged parts and printing issue defects, it is likely that a jam occurred during the assembly process resulting in the damage to the syringes.A device history record review was completed for provided material number 301031, lot number 1056881.The review did not reveal any detected quality issues during the production of this lot that could have contributed to the reported defects.Verification of the assembly process was performed.The settings were correct and the flow of products was good.To mitigate the risk of embedded degraded resin escapes, the frequency of inspections were increased.Based on the investigation and with the returned sample analysis the symptom reported by the customer is confirmed.Complaints received for this device and reported condition will continue to be tracked and trended.Our quality team regularly reviews the collected data for identification of emerging trends.
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Event Description
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It was reported that 210 bd syringe 20ml ll bns contained foreign matter, 24 lacked scale marking permanency, and 45 were damaged, but still operable.The following information was provided by the initial reporter: "it was reported that user facility reporting syringe defects for month of september, black dots, bad impression, damage/broken pieces.".
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Search Alerts/Recalls
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