BECTON DICKINSON MEDICAL DEVICES CO., LTD. SUZHOU BD INTIMA II¿ IV CATHETER; INTRAVASCULAR CATHETER
|
Back to Search Results |
|
Catalog Number 383078 |
Device Problem
Device Contamination with Chemical or Other Material (2944)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 12/01/2020 |
Event Type
malfunction
|
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 prior to use with bd intima ii¿ iv catheter foreign matter was discovered.The following information was provided by the initial reporter, translated from (b)(6) to english: due to general anesthesia, the patient needs to use an indwelling needle at 10:57.When the package is unpacked and inspected, it is found that there is a thread of flocculation at the base of the pillow.If it is not found to continue to use, it will cause the patient's rash, skin allergic reaction or redness and swelling.Serious adverse events such as necrosis and infection.Stop using it immediately.
|
|
Event Description
|
It was reported that prior to use with bd intima ii¿ iv catheter foreign matter was discovered.The following information was provided by the initial reporter, translated from chinese to english: due to general anesthesia, the patient needs to use an indwelling needle at 10:57.When the package is unpacked and inspected, it is found that there is a thread of flocculation at the base of the pillow.If it is not found to continue to use, it will cause the patient's rash, skin allergic reaction or redness and swelling.Serious adverse events such as necrosis and infection.Stop using it immediately.
|
|
Manufacturer Narrative
|
H6: investigation summary: a device history review was conducted for lot number 9323968.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 devices were found to be free of any damage or other abnormalities.Unfortunately without the ability to investigate the affected unit our quality engineers were unable to determine the root cause for this complaint.
|
|
Search Alerts/Recalls
|
|
|