MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 1997-08-22 for ARGON PATIENT MONITORING SET 041115002A manufactured by Maxxim Medical, Inc..
[17824449]
Tubing disconnected from hub and stopcock.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1625425-1997-00067 |
| MDR Report Key | 116151 |
| Report Source | 07 |
| Date Received | 1997-08-22 |
| Date Mfgr Received | 1997-07-24 |
| Date Added to Maude | 1997-09-02 |
| 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 |
| Remedial Action | PM |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ARGON PATIENT MONITORING SET |
| Generic Name | 6" EXTENSION LINE W/STOPCOCK |
| Product Code | FLN |
| Date Received | 1997-08-22 |
| Model Number | NA |
| Catalog Number | 041115002A |
| Lot Number | 97020867 |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 113967 |
| Manufacturer | MAXXIM MEDICAL, INC. |
| Manufacturer Address | 1445 FLAT CREEK RD. ATHENS TX 75751 US |
| Baseline Brand Name | ARGON PVC EXTENSION TUBE & STOPCOCK |
| Baseline Generic Name | PVC EXTENSION TUBE & STOPCOCK |
| Baseline Model No | * |
| Baseline Catalog No | 041115002A |
| Baseline ID | * |
| Baseline Device Family | PATIENT MONITORING |
| Baseline Shelf Life [Months] | NA |
| Baseline PMA Flag | N |
| Baseline 510K PMN | N |
| Baseline Preamendment | Y |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1997-08-22 | |
| 2 | 0 | 1997-08-22 |