Catalog Number 400051 |
Device Problem
Defective Component (2292)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 10/23/2023 |
Event Type
malfunction
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Manufacturer Narrative
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H.3.A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.
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Event Description
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It was reported that the bd syringe nrfit¿ slip stopper was defective/damaged.The following information was provided by the initial reporter: "when the nrfit syringe slip 5ml was opened, the plunger tip seems damaged.The nrfit syringe slip 5ml was not used to treat the patient.".
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Event Description
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No additional information.
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Manufacturer Narrative
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(b)(4) ¿ follow up mdr for device evaluation.One video and one photo of a 5ml nrfit syringe were received by bd.A quality engineer was able to review the photos from lot number 0083149 regarding material number 400051.Both the photo and video show the stopper jammed between the barrel and the plunger rod.The condition observed is non-conforming per product specification.A notification for this defect was written during the production of this lot.A requalification was performed, and the line cleared of defects.However, it is possible a limited number of pieces with this condition were able to escape detection.Potential root cause for the jammed stopper defect is associated with the assembly process.A device history record review was completed for provided lot number 0083149 showing no rejected inspections or quality issues during the production of the provided lot number that could have contributed to the reported defect.We appreciate you taking the time to bring this observation to our attention.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.
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Search Alerts/Recalls
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