Catalog Number 383028 |
Device Problem
Leak/Splash (1354)
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Patient Problems
Pain (1994); Tissue Damage (2104)
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Event Date 11/07/2019 |
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 the tubing is leaking during use with a bd intima-ii¿ closed iv catheter system.The following information was provided by the initial reporter, translated from (b)(6) to english: after the retention needle puncture, straighten the hose to begin infusion, found that the hose interface is leaking.Replace the new retention needle, re-piercing, increase the patient's pain, the retention needle no abnormality.
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Event Description
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It was reported that the tubing is leaking during use with a bd intima-ii¿ closed iv catheter system.The following information was provided by the initial reporter, translated from chinese to english: after the retention needle puncture, straighten the hose to begin infusion, found that the hose interface is leaking.Replace the new retention needle, re-piercing, increase the patient's pain, the retention needle no abnormality.
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Manufacturer Narrative
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Investigation: a device history review was conducted for lot number 9170828.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.
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Search Alerts/Recalls
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