Catalog Number 302499 |
Device Problems
Leak/Splash (1354); 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 08/20/2021 |
Event Type
malfunction
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Manufacturer Narrative
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A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.
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Event Description
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It was reported that syringe 10ml ll 21ga 1-1/2in bil lax was damaged and had foreign matter.The following information was provided by the initial reporter: when uncapping two 10 ml syringes, a broken syringe is observed at the bottom near the injection site and a brownish tip / material / stain is identified on the second syringe.Therefore it was not possible to use either of the two units.It is detected before use in patients.
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Manufacturer Narrative
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H6: investigation summary three photos were received by our quality team for analysis.Based on visual inspection of the photos, the reported incidents can be verified.A review of the internal manufacturing device records for the reported lot number was performed.The batch was inspected and released in accordance with the procedures.The breakage of the syringe could be due to the body of the barrel lacking material, which leads to perforation.The "brownish tip / material / stain" identified on the second syringe could be due to the material being burned.The most probable root cause for both incidents can be traced to the molding process, specifically damaged seals within the mold.When a seal is damaged or destroyed, the mold begins to leak material that accumulates on the mold.This accumulation of material does not allow the mold to properly inject the resin.H3 other text : see h10.
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Event Description
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It was reported that syringe 10ml ll 21ga 1-1/2in bil lax was damaged and had foreign matter.The following information was provided by the initial reporter: when uncapping two 10 ml syringes, a broken syringe is observed at the bottom near the injection site and a brownish tip / material / stain is identified on the second syringe.Therefore it was not possible to use either of the two units.It is detected before use in patients.
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Search Alerts/Recalls
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