MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2011-07-27 for COULTER? LYSE S? III DIFF LYTIC REAGENT 8546796 manufactured by Beckman Coulter, Inc..
[2133912]
The customer contacted beckman coulter, inc. (bec) to report that coulter lyse s iii diff lytic reagent was observed leaking from the foil seal of the reagent container. No patient samples were being analyzed at the time of the event. There was no impact to patient treatment. The customer reported that the foil seal appeared to be intact and there was no visible damage to the seal or container. The customer was wearing personal protective equipment (ppe - gown, gloves, goggles) at the time of the event. There was no injury or exposure to the customer. The customer did not seek medical attention. The customer has an exposure control/risk management plan in place. The customer did not review the material safety data sheet (msds); however, it is readily available. A replacement container of coulter lyse s iii diff lytic reagent was sent to the customer. The root cause of this event has not yet been determined.
Patient Sequence No: 1, Text Type: D, B5
[9272685]
Beckman coulter, inc. Urges its customers to comply with all national health and safety standards such as the use of barrier protection. This may include, but it is not limited to, protective eyewear, gloves, and suitable laboratory attire when operating or maintaining this or any other automated laboratory analyzer.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1061932-2011-00956 |
| MDR Report Key | 2180424 |
| Report Source | 05,06 |
| Date Received | 2011-07-27 |
| Date of Report | 2011-06-22 |
| Date of Event | 2011-06-22 |
| Date Mfgr Received | 2011-06-22 |
| Device Manufacturer Date | 2011-04-27 |
| Date Added to Maude | 2012-06-18 |
| 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. NORA ZEROUNIAN |
| Manufacturer Street | 250 S. KRAEMER BLVD. |
| Manufacturer City | BREA CA 92821 |
| Manufacturer Country | US |
| Manufacturer Postal | 92821 |
| Manufacturer Phone | 7149613634 |
| Manufacturer G1 | BECKMAN COULTER, INC. |
| Manufacturer Street | 11800 SW 147TH AVENUE |
| Manufacturer City | MIAMI FL 33196 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 33196 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | COULTER? LYSE S? III DIFF LYTIC REAGENT |
| Generic Name | RED CELL LYSING REAGENT |
| Product Code | GGK |
| Date Received | 2011-07-27 |
| Catalog Number | 8546796 |
| Lot Number | 101605F |
| Device Expiration Date | 2012-04-26 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BECKMAN COULTER, INC. |
| Manufacturer Address | 11800 SW 147TH AVENUE MIAMI FL 33196 US 33196 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-07-27 |