Catalog Number 383328 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Abscess (1690); Inflammation (1932)
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Event Date 03/11/2020 |
Event Type
Injury
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Manufacturer Narrative
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Date of event: unknown.The date received by manufacturer has been used for this field.Multiple lot numbers: there were multiple lot numbers reported to be involved.The information for each lot number is as follows: medical device lot #: 9119696.Medical device expiration date: 2023-04-30.Device manufacture date: 2019-05-21.Medical device lot #: 9057767.Medical device expiration date: 2023-02-28.Device manufacture date: 2019-03-15.A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.
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Event Description
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It was reported that bd saf-t-intima¿ iv catheter safety system was used and the patient developed severe inflammation.This was discovered use.The following information was provided by the initial reporter: over a period of 5-6 weeks, 3 patients developed severe inflammation at the puncture site (inflammation, induration, redness).One patient even had an abscess that had to be evacuated quickly.These catheters have been used for several years, the antisepsis protocol seems to have been respected, as well as the duration of insertion.Actions taken: alcohol-based dressing for the 3 patients to reduce inflammation.
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Manufacturer Narrative
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H.6.Investigation: a device history record review was completed by our quality engineer team for provided lot numbers 9119696 and 9057767.The review did not reveal any detected abnormalities during the production process that could have contributed to this defect and all quality inspections were found to be within specification.As a sample was unavailable for return, a thorough sample investigation could not be completed.Upon assembly, the product is sent for sterilization.The microbiological test results and the certificate of sterilization were reviewed for the provided lot numbers; no abnormalities were found.Based on the investigation results, an exact cause for this incident could not be identified.There are quality controls currently in place to detect this type of defect during the production process.
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Event Description
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It was reported that bd saf-t-intima¿ iv catheter safety system was used and the patient developed severe inflammation.This was discovered use.The following information was provided by the initial reporter: over a period of 5-6 weeks, 3 patients developed severe inflammation at the puncture site (inflammation, induration, redness).One patient even had an abscess that had to be evacuated quickly.These catheters have been used for several years, the antisepsis protocol seems to have been respected, as well as the duration of insertion.Actions taken: alcohol-based dressing for the 3 patients to reduce inflammation.
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Search Alerts/Recalls
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