Catalog Number 383941 |
Device Problems
Leak/Splash (1354); Defective Device (2588)
|
Patient Problem
No Known Impact Or Consequence To Patient (2692)
|
Event Date 10/16/2019 |
Event Type
malfunction
|
Manufacturer Narrative
|
Initial reporter phone #: unknown.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 during use the extension tubing burst with a bd pegasus¿ safety closed iv catheter system.The following information was provided by the initial reporter, translated from (b)(6) to english: on (b)(6) 2019, during high-pressure injection , it's noticed that the end of extension tubing burst.
|
|
Manufacturer Narrative
|
H.6.Investigation: a device history review was conducted for lot number 9141631.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 during use the extension tubing burst with a bd pegasus¿ safety closed iv catheter system.The following information was provided by the initial reporter, translated from chinese to english: on (b)(6) 2019, during high-pressure injection , it's noticed that the end of extension tubing burst.
|
|
Search Alerts/Recalls
|