Catalog Number 383033 |
Device Problem
Break (1069)
|
Patient Problem
Foreign Body In Patient (2687)
|
Event Date 04/18/2022 |
Event Type
Injury
|
Manufacturer Narrative
|
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 while using the bd intima-ii¿ closed iv catheter system, the front end of the catheter tub broke off inside the patient.The following information was provided by the initial reporter, translated from (b)(6) to english: the part of the front end of the catheter tube was broken in the body after the indwelling needle was removed for 3 days.
|
|
Manufacturer Narrative
|
H6: investigation summary: a device history review was conducted for lot number 1308293.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, functional testing was performed on retention samples for this lot, the results of these show that the tested units performed within product specifications.Unfortunately 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 while using the bd intima-ii¿ closed iv catheter system, the front end of the catheter tub broke off inside the patient.The following information was provided by the initial reporter, translated from chinese to english: the part of the front end of the catheter tube was broken in the body after the indwelling needle was removed for 3 days.
|
|
Search Alerts/Recalls
|