MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1997-05-02 for ARGON 041115-002A * manufactured by Maxxim Medical.
[18144319]
Pigtail from arterial line extension tubing came apart at mfr's connection. There had been no unusual tension on this line. Nurse intervened immediately. There was minimal blood loss and no harm to patient. The exact lot number is not known as the tubing was hung on 3/27/97 and packaging discarded. The lot number currently in use on this nursing unit is 96113253.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 89041 |
| MDR Report Key | 89041 |
| Date Received | 1997-05-02 |
| Date of Report | 1997-04-02 |
| Date of Event | 1997-03-28 |
| Date Facility Aware | 1997-03-28 |
| Report Date | 1997-04-02 |
| Date Reported to Mfgr | 1997-04-02 |
| Date Added to Maude | 1997-05-08 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ARGON |
| Generic Name | PVC EXTENSION TUBE W/MALE LUER LOCK & |
| Product Code | FLN |
| Date Received | 1997-05-02 |
| Model Number | 041115-002A |
| Catalog Number | * |
| Lot Number | UNK |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | 1 DAY |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 88039 |
| Manufacturer | MAXXIM MEDICAL |
| 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 | 1. Required No Informationntervention | 1997-05-02 |