Catalog Number 326631 |
Device Problem
Volume Accuracy Problem (1675)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 02/14/2022 |
Event Type
malfunction
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Manufacturer Narrative
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Device expiration date: unknown.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.
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Event Description
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It was reported that the bd ultra-fine¿ 3/10ml insulin syringe experienced scale marking issues.The following information was provided by the initial reporter: the scale marking was crooked.
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Manufacturer Narrative
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Device expiration date: unknown.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.
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Event Description
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It was reported that the bd ultra-fine¿ 3/10ml insulin syringe experienced scale marking issues.The following information was provided by the initial reporter: the scale marking was crooked.
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Event Description
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It was reported that the bd ultra-fine¿ 3/10ml insulin syringe experienced scale marking issues.The following information was provided by the initial reporter: the scale marking was crooked.
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Manufacturer Narrative
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The following fields were updated due to additional information: medical device lot #: 1144020 medical device expiration date: 30jun2026 device manufacture date: 24may2024 device available for eval yes returned to manufacturer on: 08mar2022 investigation summary: samples were received and an investigation was performed.This is the 1st complaint for the reported lot number.A review of the manufacturing records was performed and no non-conformances were raised in association with this type of event for this lot.Bd was able to duplicate or confirm the indicated issue and based on trend analysis no further action is required at this time.Complaints received for this device and reported condition will continue to be tracked and trended.Based on the above, no additional investigation and no corrective/preventative action (capa) or situational analysis (sa) is required at this time.
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Search Alerts/Recalls
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