Catalog Number UNKNOWN |
Device Problem
Loss of or Failure to Bond (1068)
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Patient Problems
No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/27/2021 |
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.
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Event Description
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It was reported that the statlocks did not stick well.Stated patient gotten them from the doctor¿s office and thinks they might had expired.
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Manufacturer Narrative
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The reported event was inconclusive as no sample returned for evaluation.It was unknown whether the device had met relevant specifications.The product used for the treatment purposes.It was unknown whether the product had caused the reported failure.A potential root cause for this failure mode could be due to the adhesive chemistry not appropriate for the application (poor quick stick characteristics).The device was not returned for evaluation.The lot number was unknown therefore the device history record could not be reviewed.The product catalog number and the lot number for this device was unknown.Therefore bd was unable to determine the associated labeling to review.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.
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Event Description
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It was reported that the statlocks did not stick well.It was also stated that the patient received them from the doctors office and thought that the statlock might expire.
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Search Alerts/Recalls
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