MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 1999-03-22 for MUCUS SPECIMEN TRAP 40CC * DYND44000 manufactured by Medline Industries, Inc..
[15037226]
Reportedly, the tubing came off the container after the specimen had been collected from a human immunodeficiency virus positive patient. The employee, reportedly, was splashed in the face with the specimen. The employee was not wearing protective goggles. The employee is being tested for possible exposure to human immunodeficiency virus.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1417592-1999-00010 |
| MDR Report Key | 215630 |
| Report Source | 05,06 |
| Date Received | 1999-03-22 |
| Date of Report | 1999-02-22 |
| Date of Event | 1999-02-21 |
| Date Facility Aware | 1999-02-21 |
| Report Date | 1999-03-22 |
| Date Reported to FDA | 1999-03-02 |
| Date Mfgr Received | 1999-02-22 |
| Date Added to Maude | 1999-03-25 |
| 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 | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MUCUS SPECIMEN TRAP 40CC |
| Generic Name | MUCUS TRAP |
| Product Code | BYZ |
| Date Received | 1999-03-22 |
| Model Number | * |
| Catalog Number | DYND44000 |
| Lot Number | UNK |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 209171 |
| Manufacturer | MEDLINE INDUSTRIES, INC. |
| Manufacturer Address | ONE MEDLINE PL. MUNDELEIN IL 60060 US |
| Baseline Brand Name | MUCUS SPECIMEN TRAP |
| Baseline Model No | * |
| Baseline Catalog No | DYND44000 |
| Baseline ID | * |
| Baseline Shelf Life [Months] | NA |
| Baseline PMA Flag | N |
| Baseline 510K PMN | Y |
| Premarket Notification | K913643 |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1999-03-22 |