MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,06 report with the FDA on 2011-10-05 for LH 700 SERIES RETIC PAK LH 700 RETIC PAK 8547196 manufactured by Beckman Coulter Inc..
[2348799]
A beckman coulter inc (bec) (b)(4) representative reported receiving a damaged a bottle of lh700 series retic pak which leaked and exposed the remaining bottle to the liquid. The event was discovered at the receiving inspection during the visual check. The employees wore personal protective equipment (ppe) when handling the reagent. The reagent was stored in quarantine and identified as non-conformant. No injuries occurred and medical attention was not sought. No report of exposure to mucous membranes or open wounds. No death, injury or change to patient treatment attributed or associated to this complaint. Service was not dispatched for this event. Root cause is unknown.
Patient Sequence No: 1, Text Type: D, B5
[9309270]
(b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1061932-2011-01622 |
| MDR Report Key | 2278107 |
| Report Source | 01,06 |
| Date Received | 2011-10-05 |
| Date of Report | 2011-09-05 |
| Date of Event | 2011-09-05 |
| Date Mfgr Received | 2011-09-05 |
| Device Manufacturer Date | 2011-06-21 |
| Date Added to Maude | 2012-06-29 |
| 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 |
| Reporter Occupation | MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE |
| 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 BVLD |
| Manufacturer City | BREA CA 92821 |
| Manufacturer Country | US |
| Manufacturer Postal | 92821 |
| Manufacturer Phone | 7149613634 |
| Manufacturer G1 | BECKMAN COULTER INC. |
| Manufacturer Street | 11800 SW 147TH AVE |
| Manufacturer City | MIAMI FL 33196 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 33196 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | N/A |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | LH 700 SERIES RETIC PAK |
| Generic Name | PRODUCTS, RED-CELL LYSING PRODUCTS |
| Product Code | GGK |
| Date Received | 2011-10-05 |
| Model Number | LH 700 RETIC PAK |
| Catalog Number | 8547196 |
| Lot Number | 57177K |
| ID Number | N/A |
| Device Expiration Date | 2012-05-30 |
| Operator | OTHER |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BECKMAN COULTER INC. |
| Manufacturer Address | 11800 SW 147TH AVE MIAMI FL 33196 US 33196 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-10-05 |