FDA Adverse Event
Malfunction
Summary report: N
AVANTI J-HC CENTRIFUGE
MDR report key: 2544067
·
Received April 20, 2012
Report
- Report Number
- 2050012-2012-01023
- Event Type
- Malfunction
- Date Received
- April 20, 2012
- Date of Event
- March 29, 2012
- Report Date
- March 29, 2012
- Manufacturer
- BECKMAN COULTER, INC.
- Product Code
- JQC
- PMA / PMN Number
- EXEMPT
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IC
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
UPON FURTHER REVIEW, THE REPORTED INCIDENT IS DETERMINED TO BE NOT REPORTABLE. THE INITIAL INCIDENT REPORT WAS INADVERTENTLY FILED TO THE AGENCY.
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
THE AFFILIATE REPORTED THE CUSTOMER ALLEGED APPROXIMATELY FIFTY PERCENT OF THE LINERS USED IN ROTOR JS-5.0 LEAKED A SUBSTANCE INVOLVING AVANTI J-HC CENTRIFUGE. THE CUSTOMER STATED THE MATERIAL AT THE BOTTOM OF THE LINER APPEARED THIN AND BREAKS. A REPLACEMENT FROM ANOTHER BATCH INVENTORY HAS BEEN ORDERED FOR THE CUSTOMER. THERE WAS NO REPORT OF INJURY OR ADVERSE EFFECT ASSOCIATED WITH THIS INCIDENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | AVANTI J-HC CENTRIFUGE | CENTRIFUGES (MICRO, ULTRA, REFRIGERATED) FOR CLINICAL USE | JQC | BECKMAN COULTER, INC. | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |