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 2012-04-26 for SYNCHRON SYSTEMS DRUG CALIBRATOR 2 469630 manufactured by Beckman Coulter, Inc..
[2752871]
Customer called to report that a new kit of synchron systems drug calibrator 2 was opened, and vial / level #5 was found nearly empty. Customer noticed evidence of leakage inside the box. Customer then opened a second kit of the same lot, lot #m101710, and found that vial / level #6 was completely empty. Again, customer noticed evidence of leakage inside the box. Customer was wearing personal protective equipment (ppe) consisting of a laboratory coat, eye protection / goggles and gloves. Customer did not come in contact with the fluid, and medical attention was not sought. There was no report of exposure to mucous membranes or open wounds, and no one was splashed or sprayed. There was no death, injury or change to patient treatment attributed to or associated with this complaint. There was no impact to patient samples or results.
Patient Sequence No: 1, Text Type: D, B5
[9817018]
Customer did not find any visible damage to the vials, and did not return the shipment for inspection. Although the cause of the vial leak was not determined, it may be assumed that the container was cracked or damaged due to transit of the shipment. A beckman coulter, inc representative sent two replacement kits to customer. (b)(4). Customer did not return shipment.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2050012-2012-01057 |
| MDR Report Key | 2551130 |
| Report Source | 01,05,06 |
| Date Received | 2012-04-26 |
| Date of Report | 2012-04-13 |
| Date of Event | 2012-04-12 |
| Date Mfgr Received | 2012-04-13 |
| Device Manufacturer Date | 2011-04-25 |
| Date Added to Maude | 2012-09-14 |
| 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. DUNG NGUYEN |
| Manufacturer Street | 250 S. KRAEMER BLVD. |
| Manufacturer City | BREA CA 928216232 |
| Manufacturer Country | US |
| Manufacturer Postal | 928216232 |
| Manufacturer Phone | 7149614941 |
| Manufacturer G1 | BECKMAN COULTER, INC. |
| Manufacturer Street | 250 S. KRAEMER BLVD. |
| Manufacturer City | BREA CA 92821623 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 92821 6232 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SYNCHRON SYSTEMS DRUG CALIBRATOR 2 |
| Generic Name | CALIBRATORS, DRUG SPECIFIC |
| Product Code | DLJ |
| Date Received | 2012-04-26 |
| Model Number | NA |
| Catalog Number | 469630 |
| Lot Number | M101710 |
| Device Expiration Date | 2013-04-30 |
| Operator | HEALTH PROFESSIONAL |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BECKMAN COULTER, INC. |
| Manufacturer Address | 250 S. KRAEMER BLVD. BREA CA 92821623 US 92821 6232 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2012-04-26 |