Model Number 309657 |
Device Problems
Leak/Splash (1354); Free or Unrestricted Flow (2945)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 12/28/2019 |
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 air leaked past the plunger into the bd luer-lok¿ disposable syringe with bd luer-lok¿ tip and allowed insulin to leak out during use.This occurred on 2 separate occasions, but the dates are unknown.This complaint was created to capture the 2nd of 3 related incidents.The following information was provided by the initial reporter: "customer reports syringe issue.Contact states that the plunger on the syringe was letting air in and letting insulin come out through it (opposite side of the needle where the plunger slides).".
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Event Description
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It was reported that air leaked past the plunger into the bd luer-lok¿ disposable syringe with bd luer-lok¿ tip and allowed insulin to leak out during use.This occurred on 2 separate occasions, but the dates are unknown.This complaint was created to capture the 2nd of 3 related incidents.The following information was provided by the initial reporter: "customer reports syringe issue.Contact states that the plunger on the syringe was letting air in and letting insulin come out through it (opposite side of the needle where the plunger slides).".
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Manufacturer Narrative
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H.6.Investigation summary: two samples received for investigation, test were performed including leakage and defects on molding for barrel, plunger rod, and/or stopper.Upon observation, there is damage to the barrel.Possible root cause, is barrel damage during manufacturing.As this occurrence would not exceed the acceptable quality limit (aql) for the batch no corrective or preventative actions are proposed in the scope of this complaint.During the documentary review, records of quality notifications that could cause the defect reported by the client were not observed.The lot was inspected according to the current work instruction with satisfactory results for the characteristics required for its approval including functional tests.No non-conforming part that could be attributable to the defect reported by the client was presented.No deviations (quality notifications) were reported during the manufacturing process.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored monthly.Our business team regularly reviews the collected data for identification of emerging trends.H3 other text : see section h.10.
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Search Alerts/Recalls
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