Catalog Number MP5303-C |
Device Problems
Leak/Splash (1354); Loose or Intermittent Connection (1371)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 01/19/2023 |
Event Type
malfunction
|
Manufacturer Narrative
|
Medical device expiration date: unknown.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.
|
|
Event Description
|
It was reported that the bd maxplus¿ pressure rated extension set with removable needleless connector had a loose connection to the piv and leaked during use.The following information was provided by the initial reporter: "nurse describes "leaking" from connection between piv and extension set.Likely due to not being able to properly connect the extension set to the piv.".
|
|
Manufacturer Narrative
|
H6: investigation summary: no photo or sample was received for the customer's complaint of connection issues.Without further information like a physical sample for investigation, the complaint cannot be verified and root cause of this failure remains unknown.A device history record review could not be performed because a lot number was not provided by the customer.
|
|
Event Description
|
It was reported that the bd maxplus¿ pressure rated extension set with removable needleless connector had a loose connection to the piv and leaked during use.The following information was provided by the initial reporter: "nurse describes "leaking" from connection between piv and extension set.Likely due to not being able to properly connect the extension set to the piv.".
|
|
Search Alerts/Recalls
|