MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2012-06-26 for BECKMAN SYNCHRON TRIGLYCERIDES REAGENT 445850 manufactured by Beckman Coulter, Inc..
[2729284]
A beckman coulter representative reported that a shipping package was returned by the carrier as damaged with a comment that read "product was leaked upon. " the proper ppe (personal protective equipment) was used when handling the product. No one came in contact with the fluid, and medical attention was not sought. There was no report of exposure to mucous membranes or open wounds, and no one was splashed or sprayed.
Patient Sequence No: 1, Text Type: D, B5
[10060342]
Included in this package was a container for beckman synchron triglycerides reagent. There is no information to indicate whether all or any of the enclosed products leaked. The product was returned in a salvage drum and inside a poly bag. The products included in the package were the following: cx triglyceride reagent 2 x 300 test: p/n (b)(4), lot m112262, manufacturing (mfg) date: 01/24/2012, expiration (exp) date: 07/31/2013; cx/lx lip kit 2 x 60 test: p/n (b)(4), lot m111230, mfg date: 01/25/2012, exp date: 07/31/2013; cx/lx alp kit 2 x 400 test: p/n (b)(4), lot m201203, mfg date: 02/09/2012, exp date: 08/31/2013; cx/lx alt kit 2 x 400 test: p/n (b)(4), lot m112250, mfg date: 02/10/2012, exp date: 08/31/2013. Hdl direct 2 x 200 test cartridge: p/n (b)(4), lot m112244, mfg date: 01/17/2012, exp date: 07/31/2013. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2050012-2012-01319 |
| MDR Report Key | 2628405 |
| Report Source | 07 |
| Date Received | 2012-06-26 |
| Date of Report | 2012-06-01 |
| Date of Event | 2012-06-01 |
| Date Mfgr Received | 2012-06-01 |
| Device Manufacturer Date | 2012-01-24 |
| Date Added to Maude | 2012-10-16 |
| 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 928216232 |
| Manufacturer Country | US |
| Manufacturer Postal | 928216232 |
| Manufacturer Phone | 7149614941 |
| Manufacturer G1 | BECKMAN COULTER, INC. |
| Manufacturer Street | 250 S. KRAEMER BLVD. |
| Manufacturer City | BREA CA 92821623 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 92821 6232 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BECKMAN SYNCHRON TRIGLYCERIDES REAGENT |
| Generic Name | LIPASE HYDROLYSIS/GLYCEROL KINASE ENZYME, TRIGLYCERIDES |
| Product Code | CDT |
| Date Received | 2012-06-26 |
| Model Number | NA |
| Catalog Number | 445850 |
| Lot Number | M112262 |
| Device Expiration Date | 2013-07-31 |
| Operator | OTHER |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BECKMAN COULTER, INC. |
| Manufacturer Address | 250 S. KRAEMER BLVD. BREA CA 92821623 US 92821 6232 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2012-06-26 |