Catalog Number 383028 |
Device Problems
Leak/Splash (1354); Device Contamination with Chemical or Other Material (2944)
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Patient Problem
Device Embedded In Tissue or Plaque (3165)
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Event Date 12/05/2019 |
Event Type
Injury
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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 patient left hospital with catheter still inserted, family members attempted to remove but catheter broke off in vein with a bd intima-ii¿ closed iv catheter system.The following information was provided by the initial reporter, translated from (b)(6) to english: during the hospitalization, on december 4, it was unclear whether the patient had sought the consent of the medical staff or the doctor on duty.After the treatment, the patient left the hospital and went home by himself.At around 9:00 a.M.On december 5, the patient's family pulled out the indwelling needle at home by themselves and found that the catheter part of the front end of the isolation plug of the indwelling needle was indwelling in the patient's body.After the occurrence of problems, the patient's guardian found the head nurse and conducted b-ultrasound examination in the hospital.The b-ultrasound location found that the broken tube was 1.8cm away from the puncturing point, suggesting surgical removal during this process, the sales rep had reminded the head nurse that the patient was not recommended to move the patient during this period because of the catheter drifting with the blood.The head nurse also informed the patient's family of the possible risks according to this reminder.It was not clear whether the product in question had been reserved or not, and it was not possible to confirm whether the sample had been returned.
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Event Description
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It was reported that the patient left hospital with catheter still inserted, family members attempted to remove but catheter broke off in vein with a bd intima-ii¿ closed iv catheter system.The following information was provided by the initial reporter, translated from chinese to english: 1.During the hospitalization, on december 4, it was unclear whether the patient had sought the consent of the medical staff or the doctor on duty.After the treatment, the patient left the hospital and went home by himself.
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Manufacturer Narrative
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H.6.Investigation summary since no samples displaying the condition reported are available for examination, we were unable to fully investigate this incident.A device history review was conducted for lot number 9141710.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.Retention samples were selected from bd inventory for evaluation/testing and upon completion, no issues were observed.Without the ability to investigate the affected unit our quality engineers were unable to determine the root cause.Our business team regularly reviews the collected data for identification of emerging trends.Based on no sample, the investigation concluded, bd was not able to verify the indicated failure.
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Search Alerts/Recalls
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