Catalog Number 309628 |
Device Problem
Loose or Intermittent Connection (1371)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 11/14/2022 |
Event Type
malfunction
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Manufacturer Narrative
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The customer's address is unknown.(b)(6) has been used as a default.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 the bd luer-lok¿ tip syringe plunger was loose and wouldn't hold it's place while preparing the dose of eylea.The following information was provided by the initial reporter: "on (b)(6) 2022, the reporter contacted.Information requesting replacement for one eylea vial.She stated that when the physician was priming the medication and tried to push up on the plunger, the plunger would not hold its place.The plunger did not fall out but rather it wouldn't hold its place.Vial difficulty preparing the dose.".
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Manufacturer Narrative
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H6: investigation summary: no samples received by our quality team for evaluation.According to verbatim, the complaint appears to be for the absence of retaining ring in the syringe barrel.This product does not have a retaining ring by design according to its product specification.Since the reported condition is likely related to the product design and the photos received did not indicate any defects a potential root cause could not be established.The reported condition is related to product design and not a true defect.Therefore, a dhr review is not required.
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Event Description
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It was reported that the bd luer-lok¿ tip syringe plunger was loose and wouldn't hold it's place while preparing the dose of eylea.The following information was provided by the initial reporter: "on 14-nov-2022, the reporter contacted.Information requesting replacement for one eylea vial.She stated that when the physician was priming the medication and tried to push up on the plunger, the plunger would not hold its place.The plunger did not fall out but rather it wouldn't hold its place.Vial difficulty preparing the dose".
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Search Alerts/Recalls
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