Catalog Number 383028 |
Device Problems
Leak/Splash (1354); Device Contamination with Chemical or Other Material (2944)
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Patient Problems
Injury (2348); Device Embedded In Tissue or Plaque (3165)
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Event Date 06/08/2019 |
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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It was reported that during use of the bd intima-ii¿ closed iv catheter system, the nurse found the catheter broken with resistance in removing catheter.Hand surgery was needed to remove the remaining broken parts of the catheter.The patient had an additional wound on his hand and an additional treatment procedure.Foreign complaint the following information was provided by the initial reporter, translated from (b)(6) to english: it was found catheter broke and discovery of resistance after withdraw, operating nurses directly press the forearm vein and tie the pulse band.Several departments in the hospital cooperated with the examination and remove the broken part of the front end of the catheter by hand surgery.The patient had an additional wound on his hand and an additional treatment procedure.
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Manufacturer Narrative
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Investigation summary: a device history review was conducted for lot number 8358948.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.Although photos were submitted for evaluation, unfortunately without the ability to investigate the affected device, the root cause for this complaint could not be determined at the conclusion of our review.
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Event Description
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It was reported that during use of the bd intima-ii¿ closed iv catheter system the nurse found the catheter broken with resistance in removing catheter.Hand surgery was needed to remove the remaining broken parts of the catheter.The patient had an additional wound on his hand and an additional treatment procedure.Foreign complaint the following information was provided by the initial reporter, translated from chinese to english: it was found catheter broke and discovery of resistance after withdraw, operating nurses directly press the forearm vein and tie the pulse band.Several departments in the hospital cooperated with the examination and remove the broken part of the front end of the catheter by hand surgery.The patient had an additional wound on his hand and an additional treatment procedure.
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Search Alerts/Recalls
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