MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06,07 report with the FDA on 2011-08-21 for DIFF AC*T TAINER DIFF ACT TAINER 8547135 manufactured by Beckman Coulter Inc..
[2163697]
.
Patient Sequence No: 1, Text Type: D, B5
[9402727]
(b)(4).
Patient Sequence No: 1, Text Type: N, H10
[20396270]
The act diff tainer kit was replaced. Service was not dispatched for this event. The root cause of the leak is unknown. Bec internal identification number is (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[20411675]
A customer contacted beckman coulter inc. (bec) to report receiving a box of the act diff tainer that leaked lytic reagent. The act diff tainer box was not opened and the customer did not know if the seal was on the bottle. The leak was absorbed by the act diff tainer box. The product was discarded. The user did not wear ppe at the time of the incident. The lab's exposure control or risk management plans are in place no injuries occurred and medical attention was not sought. There was no report of exposure to mucous membranes or open wounds. No death, injury or change to patient treatment attributed or associated to this complaint.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1061932-2011-01246 |
| MDR Report Key | 2218105 |
| Report Source | 06,07 |
| Date Received | 2011-08-21 |
| Date of Report | 2011-07-21 |
| Date of Event | 2011-07-21 |
| Date Mfgr Received | 2011-07-21 |
| Device Manufacturer Date | 2011-05-23 |
| Date Added to Maude | 2012-06-21 |
| 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 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 | DIFF AC*T TAINER |
| Generic Name | RED CELL LYSING REAGENT |
| Product Code | GGK |
| Date Received | 2011-08-21 |
| Model Number | DIFF ACT TAINER |
| Catalog Number | 8547135 |
| Lot Number | 115130K |
| ID Number | N/A |
| Device Expiration Date | 2012-03-04 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| 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 | 2011-08-21 |