Model Number 381433 |
Device Problem
Retraction Problem (1536)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 10/07/2021 |
Event Type
malfunction
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Event Description
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It was reported that at least one bd insyte¿ autoguard¿ shielded iv catheter experienced a needle that would not retract.The following information was provided by the initial reporter: a case of iv catheters are not retracting properly into the hub.
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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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Manufacturer Narrative
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H.6.Investigation: our quality engineer inspected the samples submitted for evaluation.Bd received 154 sealed 20g x 1.00in.Insyte autoguard units from lot number 1187258.A gross visual inspection of the returned units did not find any damage to the components.76 of the units were randomly selected to be functionally tested for needle retraction time.45 of the tested units were found to be out of specification with the result of slow retraction time or no retraction at all within the test time period.The remaining units were then tested by inspecting and retracting them with the catheter adapter removed from the unit.Inspection found that there was excessive gel visible in the grip.No other anomalies were noted on the components or spring.When tested, the units retracted slowly, indicating that the slow retraction was not being caused by the catheter adapter.This left the needle assembly as the source of the defect, and as no other damage other than the excessive gel was found it is likely that excessive gel was causing the defect of slow retraction.The reported issue was confirmed.This type of defect may occur during manufacturing due to an incorrect amount of gel to be dispensed.Operators periodically measure the gel inside the grip by weighing the units before and after gel insertion and perform functional testing for needle retraction per the sampling plan to mitigate the risk from this type of defect.A device history record review showed no non-conformances associated with this issue during the production of this batch.
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Event Description
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It was reported that at least one bd insyte¿ autoguard¿ shielded iv catheter experienced a needle that would not retract.The following information was provided by the initial reporter: a case of iv catheters are not retracting properly into the hub.
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Search Alerts/Recalls
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