Catalog Number 328322 |
Device Problem
Manufacturing, Packaging or Shipping Problem (2975)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 09/06/2023 |
Event Type
malfunction
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Event Description
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It was reported that 10 of the bd ultra-fine¿ ii insulin syringe experienced mixed product types in a pack.The following information was provided by the initial reporter, translated from japanese to english: customer purchased the 8mm package but upon opening the packaging he identified that it was a 6mm syringe.Application to your animal.
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Manufacturer Narrative
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E.1 initial reporter phone #:(b)(6).H3.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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H.6.Investigation summary: no samples (including photos) were returned therefore the complaint could not be confirmed and the root cause is undetermined.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.Complaints received for this device and reported condition will continue to be tracked and trended.If samples are received in the future the complaint will be reopened for further investigation.
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Event Description
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It was reported that 10 of the bd ultra-fine¿ ii insulin syringe experienced mixed product types in a pack.The following information was provided by the initial reporter, translated from japanese to english: customer purchased the 8mm package but upon opening the packaging he identified that it was a 6mm syringe.Application to your animal.
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Manufacturer Narrative
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The following fields were updated due to additional information: d9: device available for eval yes, d9: returned to manufacturer on: 06-nov-2023.H.6: 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.Embecta was not 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 corrective/preventative action (capa) or situational analysis (sa) is required.
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Event Description
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It was reported that 10 of the bd ultra-fine¿ ii insulin syringe experienced mixed product types in a pack.The following information was provided by the initial reporter, translated from japanese to english: customer purchased the 8mm package but upon opening the packaging he identified that it was a 6mm syringe.Application to your animal.
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Search Alerts/Recalls
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