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 2011-08-06 for IMMUNOPREP? REAGENT SYSTEM 7546999 manufactured by Beckman Coulter, Inc..
[2131935]
The customer contacted beckman coulter, inc. (bec) to report that liquid had leaked from the reagent a bottle of their immunoprep reagent system. The customer reported that the cap to the reagent a bottle was not loose. The product was quarantined after the leak was discovered. There was no impact to patient results. Patient treatment was not impacted by this event. The customer was wearing personal protective equipment (ppe) at the time of the event. There was no exposure to the customer. The customer did not seek medical attention. There is an exposure control plan in place at the customer's facility. The customer reviewed the material safety data sheet (msds). Reagent a is a skin and eye irritant and classified as hazardous (chemical exposure) by the us osha. Service was not dispatched for this event. The root cause of this event is likely attributed to damaged packaging.
Patient Sequence No: 1, Text Type: D, B5
[9219832]
Conclusion: root cause is likely attributed to damaged packaging. The bec internal identifier for this event is (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1061932-2011-01000 |
| MDR Report Key | 2194235 |
| Report Source | 01,05,06 |
| Date Received | 2011-08-06 |
| Date of Report | 2011-05-16 |
| Date of Event | 2011-05-16 |
| Date Mfgr Received | 2011-05-16 |
| Device Manufacturer Date | 2011-03-16 |
| Date Added to Maude | 2012-06-20 |
| 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 | IMMUNOPREP? REAGENT SYSTEM |
| Generic Name | RED CELL LYSING REAGENT |
| Product Code | GGK |
| Date Received | 2011-08-06 |
| Catalog Number | 7546999 |
| Lot Number | 1099051K |
| Device Expiration Date | 2012-06-07 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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 | 2011-08-06 |