MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,06 report with the FDA on 2012-02-09 for LACTATE DEHYDROGENASE REAGENT 476841 manufactured by Beckman Coulter, Inc..
[2533724]
The customer contacted beckman coulter, inc. (bec) to report that the neck of compartment c of a lactate dehydrogenase (ld) reagent cartridge was observed to be broken off upon delivery. The reagent from compartment c of the ld reagent cartridge had leaked out. There was no impact to patient data or patient treatment associated with this event. There was no report of injury or exposure to the customer associated with this event. Medical attention was not sought. The customer reported that an exposure control/risk management plan is in place for the facility. The customer reported that the material safety data sheet (msds) was not reviewed.
Patient Sequence No: 1, Text Type: D, B5
[9590425]
The customer provided photographs of the damaged ld reagent cartridge. A definitive root cause for the broken neck of compartment c of the ld reagent cartridge has not been determined. Bec identifier for this report is (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2050012-2012-00446 |
| MDR Report Key | 2444824 |
| Report Source | 01,05,06 |
| Date Received | 2012-02-09 |
| Date of Report | 2012-01-09 |
| Date of Event | 2012-01-09 |
| Date Mfgr Received | 2012-01-09 |
| Device Manufacturer Date | 2011-05-11 |
| Date Added to Maude | 2012-08-15 |
| 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 BLVD. |
| 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 | LACTATE DEHYDROGENASE REAGENT |
| Generic Name | LACTATE DEHYDROGENASE TEST SYSTEM |
| Product Code | CFJ |
| Date Received | 2012-02-09 |
| Model Number | NA |
| Catalog Number | 476841 |
| Lot Number | Z105206 |
| ID Number | NA |
| Device Expiration Date | 2012-11-30 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| 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 92821 US 92821 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2012-02-09 |