Catalog Number 300865 |
Device Problems
Crack (1135); Leak/Splash (1354)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 08/26/2021 |
Event Type
malfunction
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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.Medical device expiration date: unknown.A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.Device manufacture date: unknown.
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Event Description
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It was reported that syringe 50ml ll had cracks and leaked.The following information was provided by the initial reporter: leakage observed when activating the syringe pump.Event#1.2 crack lines are visible on the body of the syringe.Event#2.No consequences, not used on a patient.Sample contaminated with ketamine.
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Manufacturer Narrative
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H6: investigation summary one sample received for investigation.Upon visual inspection of the samples received, liquid passed through the stopper is observed.Stopper is correctly assembled and no molding defect in any of the parts can be observed.When barrel is examined, damage between numbers 30 and 40 of the scale can be observed.This hit, is produced during assembly process and may deform the shape of the barrel leading to the leakage experienced by customer.Further testing was conducted on samples, no sign of leakage occurred.Possible root cause for damaged barrel is associated with the manufacturing process.When there is damage in the barrel, the part can be deformed causing a mis adjustment between the stopper, barrel and plunger and leading the leakage.Areas where pieces are transported in manufacturing area are protected to avoid damage on the product.Final products in this manufacturing line, for this reference are sampled and they are subjected to visual and functional inspections during the different manufacturing sub-processes according to procedures.H3 other text : see h10.
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Event Description
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It was reported that syringe 50ml ll had cracks and leaked.The following information was provided by the initial reporter: leakage observed when activating the syringe pump.Event#1.2 crack lines are visible on the body of the syringe.Event#2.No consequences, not used on a patient.Sample contaminated with ketamine.
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Search Alerts/Recalls
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