MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2004-03-22 for DISSQUICK CONNECT 43308 manufactured by Abbott Labs.
[355782]
Report received of a splash of contaminated suction liner contents. Reportedly, nasogastric suction was set up for a pt who was exsanguinating from an upper gi bleed; no shut-off valve was used. The liner overfilled. The nurse turned off the vacuum, and the nurse was sprayed with secretions from the pt port when nurse went to remove the liner. The spray landed on their clothing, shoes, and arm. They washed their arms and changed their clothing. No prophylactic medications were given or baseline lab tests were done. There were no reported adverse effects and no medical interventions were required. Though requested, no additional information was provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1713468-2004-00012 |
| MDR Report Key | 537838 |
| Report Source | 05 |
| Date Received | 2004-03-22 |
| Date of Report | 2004-02-27 |
| Date of Event | 2004-01-30 |
| Date Mfgr Received | 2004-02-27 |
| Date Added to Maude | 2004-08-09 |
| 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 DIR |
| 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 LABS |
| 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 | DISSQUICK CONNECT |
| Generic Name | SUCTION LINER |
| Product Code | LRQ |
| Date Received | 2004-03-22 |
| Model Number | NA |
| Catalog Number | 43308 |
| Lot Number | UNK |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 527086 |
| Manufacturer | ABBOTT LABS |
| Manufacturer Address | 4455 ATHERTON DR. SALT LAKE CITY UT 84123 US |
| Baseline Brand Name | DISSQUICK CONNECT |
| Baseline Generic Name | SUCTION LINER |
| Baseline Model No | NA |
| Baseline Catalog No | 43308 |
| Baseline ID | NA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2004-03-22 |