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..
[2131936]
The customer contacted beckman coulter, inc. (bec) to report that liquid had leaked from their immunoprep reagent system. The customer reported that the liquid had leaked from one bottle due to a loose cap. The customer reported that the leak was contained and the product was discarded. There was no impact to patient results. Patient treatment was not impacted by this event. The customer was wearing personal protective equipment (ppe - gloves) at the time of the event. There was no exposure to the customer. The customer did not seek medical attention. There is a risk management 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 reagent c may cause irritation of skin, eyes, mucous membranes, and upper respiratory tract and is a suspected carcinogen. Service was not dispatched for this event. The root cause of this event is attributed to a loose bottle cap.
Patient Sequence No: 1, Text Type: D, B5
[9219833]
Root cause attributed to a loose bottle cap. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1061932-2011-01002 |
| MDR Report Key | 2194237 |
| Report Source | 01,05,06 |
| Date Received | 2011-08-06 |
| Date of Report | 2011-06-05 |
| Date of Event | 2011-06-05 |
| Date Mfgr Received | 2011-06-05 |
| Device Manufacturer Date | 2011-05-04 |
| 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 | 1099053K |
| Device Expiration Date | 2012-07-26 |
| 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 |