MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2011-08-06 for IMMUNOPREP? REAGENT SYSTEM 7546999 manufactured by Beckman Coulter, Inc..
[15504370]
The customer contacted beckman coulter, inc. (bec) to report that reagent a had no foil seal on the bottle and liquid had leaked out of their immunoprep reagent system. The customer reported that the reagent a had leaked within the box. The box was disposed of per local guidelines and daily disposal methods. 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. The customer reported that there was no exposure and no hazardous material cleanup was required. The customer did not seek medical attention. The customer did not review 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 attributed to the reported missing foil seal on the reagent a bottle.
Patient Sequence No: 1, Text Type: D, B5
[15723760]
Conclusion: root cause attributed to reported missing foil seal on the reagent a bottle. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1061932-2011-00999 |
| MDR Report Key | 2194234 |
| Report Source | 05,06 |
| Date Received | 2011-08-06 |
| Date of Report | 2011-05-13 |
| Date of Event | 2011-05-13 |
| Date Mfgr Received | 2011-05-13 |
| Device Manufacturer Date | 2011-04-06 |
| 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 | 1099052K |
| Device Expiration Date | 2012-06-28 |
| Operator | OTHER |
| 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 |