MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,07 report with the FDA on 2003-12-23 for SINGLE DISP TRANSPAC IV TRANSDUCER 42620 manufactured by Abbott Laboratories.
[16819029]
Report received of a tubing separation. It was reported that the arterial line was connected to the pt with normal saline infusing to keep the line patent. The staff was moving the pt when it was reported the tubing became entangled in the bed linen and was "tugged. " the tubing disconnected at the bonded area between the safeset port and the 3-way stopcock. The nurse noticed blood backing up in the line and turned the stopcock off. There were no reported adverse patient effects. Though requested, no additional info was provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1713468-2003-00073 |
| MDR Report Key | 506921 |
| Report Source | 01,05,07 |
| Date Received | 2003-12-23 |
| Date of Report | 2003-11-27 |
| Date of Event | 2003-11-25 |
| Date Mfgr Received | 2003-11-27 |
| Date Added to Maude | 2004-01-21 |
| 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 | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Contact | THOMAS SAMPOGNA ASSOCIATE DIRECT |
| Manufacturer Street | 200 ABBOTT PARK ROAD DEPT. 389 BLDG J-45 |
| Manufacturer City | ABBOTT PARK IL 600646132 |
| Manufacturer Country | US |
| Manufacturer Postal | 600646132 |
| Manufacturer Phone | 8479353715 |
| Manufacturer G1 | ABBOTT LABORATORIES |
| Manufacturer Street | 4455 ATHERTON |
| Manufacturer City | SALT LAKE CITY UT 84123 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 84123 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SINGLE DISP TRANSPAC IV TRANSDUCER |
| Generic Name | PRESSURE MONITORING KIT |
| Product Code | BYR |
| Date Received | 2003-12-23 |
| Model Number | NA |
| Catalog Number | 42620 |
| Lot Number | UNK |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | N |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 495843 |
| Manufacturer | ABBOTT LABORATORIES |
| Manufacturer Address | 4455 ATHERTON DR. SALT LAKE CITY UT 84123 US |
| Baseline Brand Name | SINGLE DISP TRANSPAC IV TRANSDUC |
| Baseline Generic Name | PRESSURE MONITORING KIT |
| Baseline Model No | NA |
| Baseline Catalog No | 42620 |
| Baseline ID | NA |
| Baseline Device Family | MONITOR, BP, TRANSDUCER, NON-INDWELLING |
| Baseline Shelf Life Contained | * |
| Baseline Shelf Life [Months] | * |
| Baseline PMA Flag | N |
| Baseline 510K PMN | Y |
| Premarket Notification | K932188 |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2003-12-23 |