Model Number 408360 |
Device Problem
Device Markings/Labelling Problem (2911)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 07/29/2022 |
Event Type
malfunction
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Event Description
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It was reported that the bd¿ long length spinal needle experienced inconsistent labelling information.The following information was provided by the initial reporter: differing expiry date stated on the certificate of compliance and the packaging.
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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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Manufacturer Narrative
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H6: investigation summary no samples or photos were received from the customer for this investigation.Based on the investigation bd juncos was able to confirm the customer¿s failure mode.However, the product is properly labeled with the correct date.This complaint is systematic, the most probable cause is operator error.A review of the device history record was performed, and no quality issues were found during production.
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Event Description
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It was reported that the bd¿ long length spinal needle experienced inconsistent labelling information.The following information was provided by the initial reporter: differing expiry date stated on the certificate of compliance and the packaging.
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Search Alerts/Recalls
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