Catalog Number 383019 |
Device Problem
Crack (1135)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 11/05/2022 |
Event Type
malfunction
|
Event Description
|
It was reported that the bd intima ii iv catheter prn adapter cap had a crack in it.The following information was provided by the initial reporter, translated from (b)(6): "at 09:59 on (b)(6) 2022, the patient was punctured with a closed intravenous indwelling needle for infusion, and the outer packaging was checked to be intact.When opening, a crack was found in the heparin cap.".
|
|
Manufacturer Narrative
|
A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
|
|
Manufacturer Narrative
|
H6: investigation summary a device history review was conducted for lot number 1356959.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.H3 other text : see h10.
|
|
Event Description
|
It was reported that the bd intima ii¿ iv catheter prn adapter cap had a crack in it.The following information was provided by the initial reporter, translated from chinese: "at 09:59 on (b)(6) 2022, the patient was punctured with a closed intravenous indwelling needle for infusion, and the outer packaging was checked to be intact.When opening, a crack was found in the heparin cap.".
|
|
Search Alerts/Recalls
|