Catalog Number 383322 |
Device Problems
Break (1069); Mechanical Problem (1384)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 12/10/2018 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(6).A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.
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Event Description
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It was reported that bd saf-t-intima¿ integrated safety catheter system was damaged at the juncture of the paddle hub and the extension tube, which cause leakage.No serious injury or medical intervention was reported.
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Event Description
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It was reported that bd saf-t-intima¿ integrated safety catheter system was damaged at the juncture of the paddle hub and the extension tube, which cause leakage.This occurred on 2 separate occasions but the date/time and or patient information is unknown.No serious injury or medical intervention was reported.
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Manufacturer Narrative
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Describe event or problem: it was reported that bd saf-t-intima¿ integrated safety catheter system was damaged at the juncture of the paddle hub and the extension tube, which cause leakage.This occurred on 2 separate occasions but the date/time and or patient information is unknown.No serious injury or medical intervention was reported.Investigation summary: a device history review was conducted for lot number 7300727.Our records show the reported lot was manufactured on 11/23/2017 and determined that this is the only instance of defective tubing 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 the photograph submitted could not assist our engineers in the identification of the failure mode, and 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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