MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2000-03-30 for CUSTOM MONITORING SET 46084 manufactured by Abbott Laboratories.
[178484]
Leak of pressure monitoring kit reported. A pt was hooked up to a pressure monitoring kit and a cardiac catheterization procedure started. The tubing leaked when injector use was started. A blister was noted in the tubing at the female end of the tubing where they attach to an injector or syringe. There was no report of bleedback or blood loss. A clinician reported that st segment elevation occurred as if air had been injected into the pt, but no air was noted on fluoroscopy. An unspecified dose of nitroglycerin was started and the st segment returned to a more normal range. The tubing was changed to solve the problem. No adverse sequelae to the pt reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1713468-2000-00018 |
| MDR Report Key | 272274 |
| Report Source | 05 |
| Date Received | 2000-03-30 |
| Date of Report | 2000-03-07 |
| Date of Event | 2000-03-07 |
| Date Mfgr Received | 2000-03-07 |
| Device Manufacturer Date | 2000-01-01 |
| Date Added to Maude | 2000-04-06 |
| 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 |
| Manufacturer Contact | JILL SACKETT DIRECTOR |
| Manufacturer Street | 200 ABBOTT PARK RD. DEPT 389, AP30 |
| Manufacturer City | ABBOTT PARK IL 600646157 |
| Manufacturer Country | US |
| Manufacturer Postal | 600646157 |
| Manufacturer Phone | 8479374085 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CUSTOM MONITORING SET |
| Generic Name | HIGH PRESSURE TUBING |
| Product Code | KRK |
| Date Received | 2000-03-30 |
| Returned To Mfg | 2000-03-15 |
| Model Number | NA |
| Catalog Number | 46084 |
| Lot Number | 61-080-SN |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 263584 |
| Manufacturer | ABBOTT LABORATORIES |
| Manufacturer Address | 4455 ATHERTON SALT LAKE CITY UT 84123 US |
| Baseline Brand Name | CUSTOM MONITORING SET |
| Baseline Generic Name | CVP MANOMETER |
| Baseline Model No | NA |
| Baseline Catalog No | 46084 |
| Baseline Device Family | MONITOR, PRESSURE, VENOUS, CENTRAL, NONPOWERED |
| Baseline Shelf Life Contained | * |
| Baseline Shelf Life [Months] | * |
| Baseline PMA Flag | N |
| Baseline 510K PMN | N |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2000-03-30 |