|
Catalog Number 2C2117K |
Device Problem
Component Missing (2306)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Type
malfunction
|
Event Description
|
It was reported that an unspecified quantity of small volume intermates were missing the blue winged luer cap.This issue was further described as, ¿no end cap on the set¿ and ¿encountered devices with no cap on the administration port¿.This issue was observed prior to patient use.There was no patient involvement.No additional information is available.
|
|
Manufacturer Narrative
|
E1: initial reporter first name - (b)(6).Should additional relevant information become available, a supplemental report will be submitted.
|
|
Manufacturer Narrative
|
Correction d4: expiration date: null value: change to ni (previously reported as n/a).H4: the lot was manufactured march 28, 2023 - march 29.2023.H10: one actual device was received for evaluation.The sample was not returned in its original unopened package.A visual inspection was performed using the naked eye which noted the blue winged luer cap was missing from the device.The reported condition was verified.The cause of the reported condition was a manufacturing issue.A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.Should additional relevant information become available, a supplemental report will be submitted.
|
|
Search Alerts/Recalls
|
|
|