BECTON DICKINSON & CO. (SPARKS) BD CALIBRATED DISPOSABLE INOCULATING LOOPS, BLUE 10¿L (20X50 LOOPS); EQUIPMENT, LABORATORY, GENERAL PURPOSE, LABELED AND PROMOTED FOR A SPECIFIC MEDI
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Catalog Number 220217 |
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 07/31/2023 |
Event Type
malfunction
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Manufacturer Narrative
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H.3.A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.
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Event Description
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It was reported that while using bd calibrated disposable inoculating loops, blue 10¿l (20x50 loops), the coc shows incorrect label information.No patient impact reported.The following information was provided by the initial reporter: "customer reports that the coc shows the product as 1 ul as opposed to 10 ul.".
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Event Description
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It was reported that while using bd calibrated disposable inoculating loops, blue 10l (20x50 loops), the coc shows incorrect label information.No patient impact reported.The following information was provided by the initial reporter: "customer reports that the coc shows the product as 1 ul as opposed to 10 ul.".
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Manufacturer Narrative
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H.6.Investigation summary: this memo serves to summarize findings on your recent complaint 8559068 on product 220217 (loops inoculating 50/tube 10 microliter), lot number 2301037, where it was observed that the material description on the certificate didn¿t match the product labeling.Event description: " customer reports that the coc shows the product as 1 ul as opposed to 10 ul." complaint history review: a review of past complaints on this product over the past 12 months does not indicate a trend on this issue.Device history record review: a review of device history record did indicate that the product description on the certificate was incorrect.Sample analysis: no photos or returns were available.An inspection of the retention samples did not show the noted defect.Evaluations results: based on the investigation, the noted defect was observed in the device history record.An error in the creation of the certificate was the cause of the discrepancy.Investigation conclusion: based on the evaluation of the investigation, the complaint was confirmed.A review of complaints does not indicate that a trend is present.No further action will be taken as this is considered to be an isolated incident.
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