Model Number 11426964 |
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 06/23/2022 |
Event Type
malfunction
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Event Description
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It was reported that the bd alaris¿ lvp 20d low sorb experienced labeling issues.The following information was provided by the initial reporter: packaging issue, tubing is mislabeled, not the right tubing and no filter.The tubing is labeled as 10010454, but what was actually received was product # 11426964.
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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: twenty-four samples of item 11426964 were submitted for quality investigation.The customer complaint of documentation error - labeled content incorrect was verified by visual inspection.Evaluation of the samples submitted shows that the label indicates that a filter was a part of the infusion set, however, when examining the samples, none of the samples has a filter assembled on the entire construction.A device history record review for model 11426964 lot number 22015543 was performed.The search showed that a total of (b)(4) units in 1 lot number was built on 19jan2022.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.The root cause of the issue seen in this complaint is misassembly caused at the manufacturing facility.H3 other text : see h10.
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Event Description
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It was reported that the bd alaris¿ lvp 20d low sorb experienced labeling issues.The following information was provided by the initial reporter: packaging issue, tubing is mislabeled, not the right tubing and no filter.The tubing is labeled as 10010454, but what was actually received was product # 11426964.
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Search Alerts/Recalls
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