Catalog Number 33302 |
Device Problems
Inadequate Instructions for Healthcare Professional (1319); Device Markings/Labelling Problem (2911)
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Patient Problems
No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
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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 device was not returned.
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Event Description
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It was reported that the product wrap print did not match the product.The complainant noted that both the 97129 and 97229 product labels were on the box, but found only one product 97129 inside it.
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Event Description
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It was reported that the product wrap print did not match the product.The complainant noted that both the 97129 and 97229 product labels were on the box, but found only one product 97129 inside it.
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Manufacturer Narrative
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The device was not returned for evaluation.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.The instructions for use were found adequate and state the following: ¿instructions for silicone self-adhesive sheath note: do not use on irritated or compromised skin.Do not use if allergic reaction occurs.If sheath has an insert, remove it (figures 1 & 2).Application: figures 3 & 4.Removal: figure 5.Not made with natural rubber latex.".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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Search Alerts/Recalls
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