CLEARLINK
Received Oct 30, 2024
Report 1416980-2024-06170 · MDR key 20566520
Device
Generic name
Set, Blood Transfusion
Manufacturer
Baxter Healthcare CorporationModel number
2C8750Catalog number
2C8750
Lot number
NI
Product problems
- Tear, Rip or Hole in Device Packaging
- Tear, Rip or Hole in Device Packaging
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
H11: THE DEVICE WAS NOT RETURNED AND THE LOT NUMBER IS UNKNOWN; THEREFORE, A DEVICE ANALYSIS COULD NOT BE COMPLETED. A NONCONFORMANCE HAS BEEN OPENED TO ADDRESS THIS ISSUE. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.
Description of Event or Problem
IT WAS REPORTED THAT THE PRIMARY PACKAGING OF AN UNSPECIFIED QUANTITY OF CLEARLINK SYSTEM Y-TYPE BLOOD/SOLUTION SETS WERE DAMAGED. THE DAMAGED PACKAGING WAS DISCOVERED PRIOR TO USE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.
Additional Manufacturer Narrative
D4: UNIQUE DEVICE IDENTIFIER (UDI) # IS BASED ON THE DI INFORMATION AS NO LOT NUMBER WAS PROVIDED BY THE REPORTER. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.