Catalog Number 383423 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Purulent Discharge (1812); Unspecified Infection (1930)
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Event Date 12/27/2017 |
Event Type
Injury
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Manufacturer Narrative
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A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
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Event Description
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On the third day of infusion, it was reported that a nurse noticed an infant¿s puncture point had developed an infection with a bd intima ii¿ iv catheter.The nurse disinfected the infant¿s area of infection with iodine, treated the infant with medication.Surgical treatment was performed to pump out the purulent fluid.The infant was discharged from the hospital on (b)(6) 2018.No further updates have been reported regarding additional treatment or medical intervention.
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Manufacturer Narrative
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Investigation results: representative samples provided by the customer.The failure mode could not be observed in the samples provided.The batch history record was reviewed; no abnormalities were noted.The representative samples passed bi aseptic testing.Other possible factors are: repeated infusion in a vein, causing the vascular wall to suffer from hyperplasia, hypertrophy, leading to phlebitis.A puncture through the vein of the patient that went undetected could result in the formation of a hematoma that can lead to local swelling and ultimately leading to phlebitis.Disinfection procedure was not adequate leading to the infection.Phlebitis can also be caused by an improper drug-ratio during infusion.Conclusion: bd could not find evidence linking the manufacture of this device to the reported failure mode.No additional corrective action is required at this time.
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Search Alerts/Recalls
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