Catalog Number 383028 |
Device Problem
Delivered as Unsterile Product (1421)
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Patient Problem
No Patient Involvement (2645)
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Event Date 09/15/2020 |
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, a supplemental report will be filed.(b)(4).
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Event Description
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It was reported that the bd intima-ii¿ closed iv catheter system needle had no cap on it and was contaminated.The following information was provided by the initial reporter, translated from (b)(6) to english: the patient was admitted to hospital on (b)(6) 2020.On (b)(6) the patient was treated with a closed intravenous indwser as prescribed by the doctor.Nurse carried the closed intravenous indwser needle to the bedside and found that the indwser needle had no cap and the needle was contaminated.Immediately explain to the patient and replace the new closed intravenous indwelling needle for the treatment of the patient.This incident delays the treatment of the patient and increases the medical cost.There is no device combination in this event.
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Event Description
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It was reported that the bd intima-ii¿ closed iv catheter system needle had no cap on it and was contaminated.The following information was provided by the initial reporter, translated from chinese to english: the patient was admitted to hospital on (b)(6) 2020.On (b)(6) 2015, the patient was treated with a closed intravenous indwser as prescribed by the doctor.Nurse carried the closed intravenous indwser needle to the bedside and found that the indwser needle had no cap and the needle was contaminated.Immediately explain to the patient and replace the new closed intravenous indwelling needle for the treatment of the patient.This incident delays the treatment of the patient and increases the medical cost.There is no device combination in this event.
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Manufacturer Narrative
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H.6.Investigation: a device history review was conducted for lot number 9050858.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; in lieu of the affected device, visual analysis was performed on retention samples for this lot, the retained units were found have all necessary components and to be free from other defects.Unfortunately without the ability to investigate the affected unit our quality engineers were unable to determine the root cause for this complaint.H3 other text : see h.10.
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Search Alerts/Recalls
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