Model Number 260678 |
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 03/03/2023 |
Event Type
malfunction
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Manufacturer Narrative
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Initial reporter phone #: (b)(6).Initial reporter addr 1: (b)(6).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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Event Description
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It was reported that while using the bd gaspak¿ ez anaerobe container system that there was a label issue.The following information was provided by the initial reporter: confirm if the lot of the box and lot of the envelopes in the catalog is normal that they are not the same.
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Event Description
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It was reported that while using the bd gaspak¿ ez anaerobe container system that there was a label issue.The following information was provided by the initial reporter: confirm if the lot of the box and lot of the envelopes in the catalog is normal that they are not the same.
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Manufacturer Narrative
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H.6 investigation summary: a complaint investigation due to incorrect labeling on gaspak ez anaerobe container catalog 260678 batch no.: 2055996 was performed on retention samples.Returned goods were not received from customer.The investigation required to perform visual inspection, incoming and batch record review.No discrepancies observed during the visual inspection.Batch record review did not show any evidence of customer claim.Incoming record not available, lot received under skip lot program.Photo received from customer was evaluated.No discrepancy observed.Raw material batch number 1272lj was used to manufacture bd batch 2055996.No corrective action is required based on information evaluated and satisfactory results obtained during the qc test.Complaint is not confirmed.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored.
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Search Alerts/Recalls
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