Catalog Number 383912 |
Device Problem
Leak/Splash (1354)
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Patient Problems
Abdominal Pain (1685); Extravasation (1842); Tissue Damage (2104)
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Event Date 02/16/2020 |
Event Type
malfunction
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Manufacturer Narrative
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Initial reporter phone #: unknown.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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It was reported that during use there were burrs on needle which damaged blood vessels and caused extravasation of the drug with a bd pegasus¿ safety closed iv catheter system.The following information was provided by the initial reporter, translated from (b)(6) to english: the patient was admitted to the hospital for treatment due to abdominal pain.During the puncturing on (b)(6) 2020 after the operation, it was found that there were burrs on the needle, which damaged the blood vessels and caused the extravasation of the drug solution.The operation was completed after the replacement of the new product.
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Manufacturer Narrative
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H.6.Investigation: a device history review was conducted for lot number 9106501.Our records show that this is the only instance of this issue occurring in this production batch.According to the sampling plan applied for product performance, this lot was accepted and released without defects being noted during the final assembly or visual inspections.Unfortunately a sample could not be obtained for evaluation and testing.Without the ability to investigate the affected unit our quality engineers were unable to determine the root cause for this complaint.H3 other text : see h.10.
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Event Description
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It was reported that during use there were burrs on needle which damaged blood vessels and caused extravasation of the drug with a bd pegasus¿ safety closed iv catheter system.The following information was provided by the initial reporter, translated from chinese to english: the patient was admitted to the hospital for treatment due to abdominal pain.During the puncturing on(b)(6)2020 after the operation, it was found that there were burrs on the needle, which damaged the blood vessels and caused the extravasation of the drug solution.The operation was completed after the replacement of the new product.
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Search Alerts/Recalls
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