MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,06 report with the FDA on 2011-11-23 for BECKMAN TOTAL BILIRUBIN TRIGGERED KIT 476826 manufactured by Beckman Coulter, Inc..
[2355354]
The customer reported that they observed a leak coming from a synchron cx4/cx5 clinical chemistry analyzer reagent. No patient results were involved in this event. It is unknown as to whether the personnel involved in this event was wearing personal protective equipment at the time of occurrence however no personnel sought medical attention in association with this event. There was no chemical exposure to personnel uncovered wounds or mucous membranes. No death, injury or modification to patient treatment was associated with this event. No exposure control plan was in place at the facility. The material safety data sheet was not reviewed.
Patient Sequence No: 1, Text Type: D, B5
[9466984]
Beckman coulter inc. Assessment of the supplied photos indicated that the cartridges were leaking from the bottom seam. This may be indicative of a cartridge manufacturing issue. No service was dispatched to the site for this event. A definitive root cause for the leak is not known at this time.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2050012-2011-07858 |
| MDR Report Key | 2346698 |
| Report Source | 01,06 |
| Date Received | 2011-11-23 |
| Date of Report | 2011-11-09 |
| Date of Event | 2011-10-26 |
| Date Mfgr Received | 2011-11-09 |
| Device Manufacturer Date | 2011-04-12 |
| Date Added to Maude | 2012-07-18 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | MS DUNG NGUYEN |
| Manufacturer Street | 250 S KRAEMER BLVD |
| Manufacturer City | BREA CA 92821 |
| Manufacturer Country | US |
| Manufacturer Postal | 92821 |
| Manufacturer Phone | 7149614941 |
| Manufacturer G1 | BECKMAN COULTER, INC. |
| Manufacturer Street | 250 S KRAEMER BOULEVARD |
| Manufacturer City | BREA CA 92821 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 92821 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BECKMAN TOTAL BILIRUBIN TRIGGERED KIT |
| Generic Name | NADH OXIDATION/NAD REDUCTION, ALT/SGPT |
| Product Code | CKA |
| Date Received | 2011-11-23 |
| Model Number | NA |
| Catalog Number | 476826 |
| Lot Number | Z104209 |
| ID Number | NA |
| Operator | OTHER |
| Device Availability | N |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BECKMAN COULTER, INC. |
| Manufacturer Address | 250 S KRAEMER BOULEVARD BREA CA 92821 US 92821 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-11-23 |