Catalog Number 381123 |
Device Problem
Device Disinfection Or Sterilization Issue (2909)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 05/28/2018 |
Event Type
malfunction
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Manufacturer Narrative
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There were multiple lot numbers reported to be involved.The information for each lot number is as follows: medical device lot #: 4057252, expiration date: 2019-03-31, manufacture date: 2014-03-21.Medical device lot #: 5357291, expiration date: 2020-12-31, manufacture date: 2016-01-22.Medical device lot #: 6026177, expiration date: 2021-01-31, manufacture date: 2016-02-15.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation and/or device history review, a supplemental report will be filed.
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Event Description
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It was reported that there was a sterile breach with several bd angiocath¿ iv catheter packages.There was no report of exposure, injury or medical intervention.
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Event Description
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It was reported that there was a sterile breach with several bd angiocath¿ iv catheter packages.There was no report of exposure, injury or medical intervention.
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Manufacturer Narrative
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Investigation summary: bd was able to verify the customer complaint for the claimed defect.There were no records of failure/ integrity of the seal in the batch history analysis and in the records of non-conformity or quality notification for the claimed batch.The complaint was verified by analyzing the sample.Although not certain, a possible cause of this defect would be a failure in the adhesiveness of the paper with the film due to the lacquer contained in the paper from the supplier.It was determined to change suppliers to one which does not use lacquer as an adhesive.
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Manufacturer Narrative
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Due to an it issue beginning on (b)(6) 2018, previously filed emdrs did not contain required fields.This supplemental emdr is filed to provide the following: device returned to manufacture: yes.
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Event Description
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It was reported that there was a sterile breach with several bd angiocath¿ iv catheter packages.There was no report of exposure, injury or medical intervention.
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Search Alerts/Recalls
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