Catalog Number 381512 |
Device Problems
Leak/Splash (1354); Device Contamination with Chemical or Other Material (2944)
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Patient Problems
No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 02/03/2021 |
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.A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.(b)(4).
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Event Description
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It was reported that insyte autoguard winged yel 24ga x.75in broke apart.This occurred on 64 occasions.The following information was provided by the initial reporter: material no: 381512, batch no: 0104316.It was reported breaking apart.
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Event Description
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It was reported that insyte autoguard winged yel 24ga x.75in broke apart.This occurred on 64 occasions.The following information was provided by the initial reporter: material no: 381512 batch no: 0104316 it was reported breaking apart.
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Manufacturer Narrative
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H6: investigation summary: bd received sixty-four unopened 24 gauge insyte autoguard units from lot 0104316 for evaluation.A review of the device history record was performed for the reported lot and no quality issues were found during production.Our quality engineer visually inspected the returned units and observed not visible damage or defects with the returned units.Next, a venipuncture test was performed and each unit was found to be within product specifications.Based off the visual inspection and testing the engineer was unable to verify the reported defect.Since no defects were found during production a definitive root cause could not be determined.H3 other text : see h10.
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Search Alerts/Recalls
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