MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2007-02-26 for ARG BUB TUBE COND 6MM X 30.5M 8888290411 manufactured by Tyco Healthcare/kendall.
[20694003]
It was reported to mfr in 2007, that the patient, who was on a ventilator, and had a nasogastric tube, went to cardiovascular and interventional radiology (cvir) for an ivc filter replacement. When the patient was transferred to the cvir table by transport and cvir, high flow oxygen (15 liters), was accidentally connected to the nasogastric tube. The patient's ivc filter replacement procedure was cancelled. Ent and surgical physicians evaluated the patient. A ct scan revealed intraperitoneal free air. The patient required emergency surgery- partial gastric resection and repair of colonic injury performed, since there was a stomach perforation and colonic serosal tear. The oxygen flowmeter was connected to the "bubble tubing" with the "5 and 1 connector" to the nasogastric tube. No sample available, sample discarded.
Patient Sequence No: 1, Text Type: D, B5
[20821360]
An investigation is currently under way. Upon completion, results will be forwarded.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9612030-2007-00012 |
| MDR Report Key | 822123 |
| Report Source | 05,06 |
| Date Received | 2007-02-26 |
| Date of Report | 2007-02-26 |
| Report Date | 2007-02-26 |
| Date Reported to FDA | 2007-02-01 |
| Date Reported to Mfgr | 2007-02-26 |
| Date Mfgr Received | 2007-02-26 |
| Date Added to Maude | 2007-03-02 |
| 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 | 3 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | JENNIFER REED |
| Manufacturer Street | 15 HAMPSHIRE STREET |
| Manufacturer City | MANSFIELD MA 02048 |
| Manufacturer Country | US |
| Manufacturer Postal | 02048 |
| Manufacturer Phone | 5082616620 |
| Manufacturer G1 | TYCO HEALTHCARE/KENDALL |
| Manufacturer Street | 9255 CUSTOMHOUSE PLAZA SUITE A |
| Manufacturer City | SAN DIEGO CA 92173 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 92173 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ARG BUB TUBE COND 6MM X 30.5M |
| Generic Name | CONNECTOR TUBING |
| Product Code | CCN |
| Date Received | 2007-02-26 |
| Model Number | 8888290411 |
| Catalog Number | 8888290411 |
| Lot Number | UNK |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | UNKNOWN |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 809528 |
| Manufacturer | TYCO HEALTHCARE/KENDALL |
| Manufacturer Address | 9255 CUSTOMHOUSE PLAZA SAN DIEGO CA 92173 US |
| Baseline Brand Name | ARG BUB TUBE COND 6MM X 30.5M |
| Baseline Generic Name | CONNECTOR TUBING |
| Baseline Model No | 8888290411 |
| Baseline Catalog No | 8888290411 |
| Baseline ID | * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2007-02-26 |