Model Number 381423 |
Device Problem
Retraction Problem (1536)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 02/01/2023 |
Event Type
malfunction
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Manufacturer Narrative
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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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Event Description
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It was reported that at least 5 bd insyte¿ autoguard¿ shielded iv catheters had issues with the needle either not retracting, or retracting very slowly.The following information was provided by the initial reporter: "needle is not retracting or retracting very slowly.The mis-retraction and failures were not counted, however occurred to all of our 5 nurses in this department.No one was injured.".
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Manufacturer Narrative
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The following fields were updated due to additional information: d10: device available for eval yes.D10: returned to manufacturer on: 21-feb-2023.Our quality engineer inspected the representative samples submitted for evaluation.Bd received 198 sealed 22ga x 1.00in.Insyte autoguard units from lot number 2284590.A sampling of 20 units were randomly chosen for needle retraction testing.All 20 units retracted fully and successfully but displayed a delay in retraction.The units should take 1 second or less to retract and all 20 units tested took longer than 1 second to retract.Further microscopic analysis discovered excess gel that went well below the coils.Gel is normal on units, but it generally does not flow too low below the coils.The reported issue of slow retraction was confirmed and determined to be manufacturing related due to excessive gel.This may occur due to an incorrect equipment setting.A quality control plan to check the weight at set-up is in place to mitigate the occurrence of this defect.A device history record review showed no non-conformances associated with this issue during the production of this batch.H3 other text : see h10.
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Event Description
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It was reported that at least 5 bd insyte¿ autoguard¿ shielded iv catheters had issues with the needle either not retracting, or retracting very slowly.The following information was provided by the initial reporter: "needle is not retracting or retracting very slowly.The mis-retraction and failures were not counted, however occurred to all of our 5 nurses in this department.No one was injured.".
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Search Alerts/Recalls
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