Catalog Number UNKNOWN |
Device Problems
Component Missing (2306); Component Misassembled (4004)
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Patient Problems
No Patient Involvement (2645); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/30/2020 |
Event Type
malfunction
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Manufacturer Narrative
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The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.The information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.
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Event Description
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It was reported that the customer received an arctic gel pad order but they did not receive the right amount of arctic gel pad and the call was transferred for assistance with order discrepancy.
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Manufacturer Narrative
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The reported event was inconclusive.No sample was returned for evaluation.A potential root cause for this failure could be ¿operator error¿.The lot number was unknown; therefore, the device history record could not be reviewed.Unable to perform labelling review due to unknown product code.Although the product family was unknown, the arctic gel pad product ifus were found to be adequate based on past reviews.H11:section a through f - the information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.H3 other text : the device was not returned.
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Event Description
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It was reported that the customer received an arctic gel pad order but they did not receive the right amount of arctic gel pad and the call was transferred for assistance with order discrepancy.
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Search Alerts/Recalls
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