Catalog Number CDC-42703-1A |
Device Problems
Device Damaged Prior to Use (2284); Device Markings/Labelling Problem (2911)
|
Patient Problem
No Patient Involvement (2645)
|
Event Date 09/04/2019 |
Event Type
malfunction
|
Manufacturer Narrative
|
(b)(4).
|
|
Event Description
|
The customer reports receiving central line kit that is mislabeled.
|
|
Manufacturer Narrative
|
(b)(4).Corrected data: results code corrected to 111.
|
|
Event Description
|
The customer reports receiving central line kit that is mislabeled.
|
|
Manufacturer Narrative
|
Qn#(b)(4).The sample was not returned; however, the customer provided two photos for evaluation.Evaluation of the photos reveals the banner card insert shows the correct part number (cdc-42703-1a) and catheter length (16cm); however, the lidstock information card displays the incorrect part number (cdc-45703-1a and catheter length (20cm).This would indicate that the incorrect lidstock information card was used during the packaging of these kits.A device history record review was performed on the manufacturing of this product and no relevant manufacturing issues were identified.The customer reported issue of the incorrect part number and catheter length being listed on the lidstock label was confirmed through evaluation of the provided photos.Evaluation of the photos revealed that the lidstock information label listed the part number as cdc-45703-1a instead of the correct number cdc-42703-1a and the catheter length as 20cm instead of the correct length 16cm.The information label is attached during packaging of the kit; therefore, the probable root cause of this issue is packaging related.A capa is currently in-process further investigate this issue.
|
|
Event Description
|
The customer reports receiving central line kit that is mislabeled.
|
|
Search Alerts/Recalls
|