MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 1999-02-22 for ABBOTT COMMANDER PPC 6208-86 manufactured by Abbott Mfg, Inc.
[17822664]
On 1/21/99 an operator was sprayed in the face with waste material from the ppc. Retesting of the samples being tested at the time of the event confirmed 6 repeat reactive hepatitis c virus samples and one confirmed positive human immunodeficiency virus sample by western immunoblot. After washing an hepatitis c virus tray, the operator noticed water on the tray and serum still in the wells. The operator then put the tray in the ppc to wash it again. While the operator was observing the ppc with the lid open, the clamp on the manifold waste tubing broke, spraying waste material in her facial area and hair. The operator was not wearing a face shield or protective eyewear.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1628664-1999-00006 |
| MDR Report Key | 211084 |
| Report Source | 05,06 |
| Date Received | 1999-02-22 |
| Date of Report | 1999-02-18 |
| Date of Event | 1999-01-21 |
| Date Mfgr Received | 1999-01-21 |
| Device Manufacturer Date | 1990-07-01 |
| Date Added to Maude | 1999-02-25 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ABBOTT COMMANDER PPC |
| Generic Name | AUTOMATED SYSTEM FOR THE PROCESSING OF EIAS |
| Product Code | LCI |
| Date Received | 1999-02-22 |
| Model Number | NA |
| Catalog Number | 6208-86 |
| Lot Number | NA |
| ID Number | NA |
| Operator | UNKNOWN |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 204836 |
| Manufacturer | ABBOTT MFG, INC |
| Manufacturer Address | 1921 HURD DR. IRVING TX 75038 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1999-02-22 |