Catalog Number 306594 |
Device Problem
Material Deformation (2976)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 02/01/2024 |
Event Type
malfunction
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Event Description
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2024-02-01 10:00 preparing for use found the pre-filler cap separated from the syringe and the syringe nipple was damaged.
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Manufacturer Narrative
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Pr (b)(4): initial mdr submission.A follow up mdr will be submitted if additional information, a device evaluation, or a device history review is completed.H3 other text : see h10 manufacture narrative.
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Manufacturer Narrative
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Pr (b)(4) follow up for device evaluation.It was reported the syringe luer was damaged.As a sample was not returned, a thorough sample evaluation could not be performed.To aid in the investigation, one photo was provided for evaluation by our quality team.The photo shows a prefilled syringe in an opened packaging flow wrap.The tip cap has been removed and the syringe barrel luer looks damaged.No other defects or imperfections were observed.A device history record review was completed for provided material number 306594, lot 3206757.The review did not reveal any detected quality issues during the production of this lot that could have contributed to the reported defect.There were no related quality notifications.All processes and final inspections complied with specification requirements.To date, there have been no other similar events reported for this lot.Based on the investigation and with the photo sample analysis the symptom reported by the customer is confirmed, but without the actual physical sample analysis a probable root cause could not be offered.
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Event Description
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No additional information received 2024-02-01 10:00 preparing for use found the pre-filler cap separated from the syringe and the syringe nipple was damaged.
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Event Description
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No additional information received: on (b)(6) 2024 10:00, preparing for use found the pre-filler cap separated from the syringe and the syringe nipple was damaged.
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Manufacturer Narrative
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(b)(4).Follow up: a device history record review was completed by our quality engineer team for provided material number: 306594 and lot number: 3206757.The review did not reveal any detected abnormalities during the production process that could have contributed to this defect and all quality tests were found to be within specification.As a sample was unavailable for return, a thorough sample investigation could not be completed.Based on the investigation results, an exact cause for this incident could not be identified.Should you again experience any problems with our product we would appreciate the opportunity to conduct a thorough analysis.There are quality controls currently in place to detect this type of defect during the production process.Further action has not been determined necessary at this time.
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Search Alerts/Recalls
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