MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 1996-11-27 for AXSYM CARBAMAZEPINE CONTROLS 7A69-10 manufactured by Abbott Health Product, Inc..
[16147797]
On 10/29/96, a lab tech at the account splashed carbamazepine control reagent into her eyes, while attempting to dispense the low control into a sample cup. The nozzle tip of the low control vial appeared to be plugged, because liquid was not expelled when the vial was pressed. The tech was removing the nozzle tip, to enable manual pipetting of the control, when the control reagent splashed into her eyes. The tech dabbed her eyes, but she did not flush at the eyewash station, nor seek medical attention. The customer called to inquire if co control reagents are tested for infectious material. She was advised, per the package insert, to note the safety precautions section and to follow lab biohazard exposure policy.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2623532-1996-00014 |
| MDR Report Key | 53072 |
| Report Source | 05 |
| Date Received | 1996-11-27 |
| Date of Report | 1996-11-27 |
| Date of Event | 1996-10-29 |
| Date Facility Aware | 1996-10-29 |
| Report Date | 1996-11-27 |
| Date Mfgr Received | 1996-10-29 |
| Device Manufacturer Date | 1995-12-01 |
| Date Added to Maude | 1996-12-04 |
| 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 | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | AXSYM CARBAMAZEPINE CONTROLS |
| Generic Name | CARBAMAZEPINE PREPARED CONTROLS |
| Product Code | KLT |
| Date Received | 1996-11-27 |
| Model Number | NA |
| Catalog Number | 7A69-10 |
| Lot Number | 12550Q100 |
| ID Number | NA |
| Device Expiration Date | 1997-06-29 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | 12 MO |
| Device Eval'ed by Mfgr | N |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 53694 |
| Manufacturer | ABBOTT HEALTH PRODUCT, INC. |
| Manufacturer Address | KM 58.0 CARRETERA 2 BARCELONETA PR 00617 US |
| Baseline Brand Name | AXSYM CARBAMAZEPINE CTL |
| Baseline Generic Name | CARBAMAZEPINE PREPARED CONTROLS |
| Baseline Model No | NA |
| Baseline Catalog No | 7A69-10 |
| Baseline ID | NA |
| Baseline Device Family | AXSYM CARBAMAZEPINE |
| Baseline Shelf Life Contained | Y |
| Baseline Shelf Life [Months] | 18 |
| Baseline PMA Flag | N |
| Baseline 510K PMN | Y |
| Premarket Notification | K953374 |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1996-11-27 |