Catalog Number 383712 |
Device Problem
Leak/Splash (1354)
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Patient Problems
Extravasation (1842); Weakness (2145); Numbness (2415)
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Event Date 08/11/2019 |
Event Type
malfunction
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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 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 during use of the bd pegasus¿ safety closed iv catheter system there was leakage at the joint.Foreign complaint the following information was provided by the initial reporter, translated from (b)(6) to english: the patient was admitted to the hospital because of "left limb weakness and numbness for 2 days".After 5 minutes of infusion, the indwelling needle was found to be infiltrated.It was found that the heparin cap joint leaked.Check that the joint has been tightened and replace the indwelling needle to re-infuse.
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Manufacturer Narrative
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H.6.Investigation summary: a device history review was conducted for lot number 9081793.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.A sample could not be obtained for evaluation and testing.Retained samples were leak tested with no leakage observed.Without the ability to investigate the affected unit our quality engineers were unable to determine the root cause for this complaint.
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Event Description
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It was reported that during use of the bd pegasus¿ safety closed iv catheter system there was leakage at the joint.Foreign complaint the following information was provided by the initial reporter, translated from chinese to english: the patient was admitted to the hospital because of "left limb weakness and numbness for 2 days".After 5 minutes of infusion, the indwelling needle was found to be infiltrated.It was found that the heparin cap joint leaked.Check that the joint has been tightened and replace the indwelling needle to re-infuse.
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Search Alerts/Recalls
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