Catalog Number UNKNOWN |
Device Problem
Explosion (4006)
|
Patient Problem
Chemical Exposure (2570)
|
Event Date 01/02/2019 |
Event Type
malfunction
|
Manufacturer Narrative
|
Device expiration date: unknown.Device manufacture date: unknown.Device evaluated by mfr: a device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
|
|
Event Description
|
It was reported that a bd saf-t-intima¿ iv catheter safety system had leakage.The following was reported, "the prn was exploded in ct imaging; the developer was exposed.Ct imaging was failed.".
|
|
Manufacturer Narrative
|
Investigation: a device history review was conducted for lot number 7327618.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.
|
|
Event Description
|
It was reported that a bd saf-t-intima¿ iv catheter safety system had leakage.The following was reported, "the prn was exploded in ct imaging; the developer was exposed.Ct imaging was failed.".
|
|
Search Alerts/Recalls
|