MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,07 report with the FDA on 2011-09-30 for IMMUNOPREP? REAGENT SYSTEM, 300 TESTS 7546999 manufactured by Beckman Coulter, Inc..
[2234647]
Beckman coulter inc. , (bec) from japan reported that liquid leaked from one of the bottles of the immunoprep reagent kit. The cap was closed and there was no observed damage to the bottle. The leak was observed during the receiving inspection process. The customer reported wearing personal protective equipment (ppe) before and during the receiving inspection process. The product was quarantined after inspection. There was no death or injury and medical attention was not required. There was no exposure to skin or mucous membranes.
Patient Sequence No: 1, Text Type: D, B5
[9474273]
There is an exposure control plan in place at the customer's facility and the material safety data sheet (msds) was reviewed. The root cause of the leak is unknown. Bec internal number: (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1061932-2011-01580 |
| MDR Report Key | 2271116 |
| Report Source | 01,07 |
| Date Received | 2011-09-30 |
| Date of Report | 2011-09-01 |
| Date of Event | 2011-09-01 |
| Date Mfgr Received | 2011-09-01 |
| Device Manufacturer Date | 2011-06-17 |
| Date Added to Maude | 2012-06-28 |
| 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 | 0 |
| 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 CULTER 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 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | IMMUNOPREP? REAGENT SYSTEM, 300 TESTS |
| Generic Name | PRODUCTS, RED-CELL LYSING PRODUCTS |
| Product Code | GGK |
| Date Received | 2011-09-30 |
| Model Number | NA |
| Catalog Number | 7546999 |
| Lot Number | 1099055K |
| ID Number | NA |
| Device Expiration Date | 2012-09-06 |
| 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 | 2011-09-30 |