Catalog Number 317-05-02 |
Device Problem
Material Separation (1562)
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Patient Problem
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 information provided by bard 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 bard.
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Event Description
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It was reported that during initiation of therapy the gel separated from the pads; as a result, therapy was delayed while another set of pads were found and used.The pads were not used on the patient.
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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 bard 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 bard.
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Manufacturer Narrative
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Received 1 set of 2 arcticgel pads with the original unit packaging.Only the chest pads were returned.Visual inspection noted that the hydrogel appeared to be separating from the pad on the right chest pad.The hydrogel layer was still stuck to the white backing.The laminated film on the pad was evaluated and was found to be with in specifications; the white film separated from the pad without any problems.The hydrogel stayed adhered to the blue foam.Visual inspection noted no further obvious defects.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.The complaint was confirmed with an unknown root cause.The instructions for use states the following: ¿remove the release liner from each pad and apply to the appropriate area.¿ (b)(4).The information provided by bard 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 bard.
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Search Alerts/Recalls
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