Catalog Number 301035 |
Device Problems
Leak/Splash (1354); Defective Component (2292)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 09/06/2022 |
Event Type
malfunction
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Event Description
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It was reported that the tip of the bd¿ luer-lok syringe was damaged and caused it to leak.This occurred with 250 syringes.The following information was provided by the initial reporter, translated from german: "customer describes that there is a kind of web on the luer-lok connection, which causes it to leak".
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Manufacturer Narrative
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Investigation summary: it was reported the syringe molding was defective causing leakage.To aid in the investigation, two photos were provided for evaluation by our quality team.The photos are magnified to show a visible tip flash.From the photos, it is not possible to confirm if the tip flash is out of specification.No other information could be obtained from the photos.A device history record review was completed for provided material number 301035, lot number 2040680.The review did not reveal any detected quality issues during the production of this lot that could have contributed to the reported defect.To date, there have been no other similar events reported for this lot.Based on the investigation and with photo sample analysis the symptom reported by the customer could not be confirmed as what is shown in the photos could be an imperfection.Without the physical sample analysis a probable root cause could not be offered.Complaints received for this device and reported condition will continue to be tracked and trended.Our quality team regularly reviews the collected data for identification of emerging trends.
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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: 02-nov-2022.H6: investigation summary: it was reported the syringe molding was defective causing leakage.To aid in the investigation, five samples with no packaging blister, and two photos were provided for evaluation by our quality team.A visual inspection was performed and each syringe has a tip flash.Each tip flash was measured and all results were within specification.The photos are magnified to show a visible tip flash.From the photos, it is not possible to confirm if the tip flash is out of specification.No other information could be obtained from the photos.A device history record review was completed for provided material number 301035, lot number 2040680.The review did not reveal any detected quality issues during the production of this lot that could have contributed to the reported defect.Based on the investigation and with returned sample analysis the symptom reported by the customer could not be confirmed, and a probable root cause could not be offered.
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Event Description
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It was reported that the tip of the bd¿ luer-lok syringe was damaged and caused it to leak.This occurred with 250 syringes.The following information was provided by the initial reporter, translated from german: "customer describes that there is a kind of web on the luer-lok connection, which causes it to leak".
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Search Alerts/Recalls
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