Catalog Number 382512 |
Device Problem
Retraction Problem (1536)
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Patient Problem
Tissue Damage (2104)
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Event Date 05/23/2019 |
Event Type
malfunction
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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.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 the needle was jammed and the bd insyte¿ autoguard¿ bc shielded iv catheter would not snap off, resulting in the patient's vein blowing up.The following information was provided by the initial reporter: "needle was jamming and the catheter would not snap off.The incident blew up the patients vein.".
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Event Description
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It was reported that the needle was jammed and the bd insyte¿ autoguard¿ bc shielded iv catheter would not snap off, resulting in the patient's vein blowing up.The following information was provided by the initial reporter: "needle was jamming and the catheter would not snap off.The incident blew up the patients vein.".
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Manufacturer Narrative
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Investigation: bd received 21 unused 24 gauge insyte autoguard blood control units from lot 9064879 for evaluation.A review of the device history record was performed for the reported lot and no quality issues were found during production.Our quality engineer visually inspected the returned units and observed no physical/mechanical damage to any of the tubing for the units.Next, the engineer checked the tip adhesion by manually rotating the clear barrels 360 degrees and no issues were found.Finally, a flashback test was performed for the returned units and flashback was seen quickly with no obstructions.Based off the visual inspection and testing the engineer was unable to verify any defects.Since no defects were observed a definitive root cause could not could not be determined.
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Search Alerts/Recalls
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