MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00,06 report with the FDA on 2000-02-25 for 86-000790 ANESTHESIA KIT-BELLIN MEMORIAL * KIT # 86-000790 manufactured by Deroyal.
[178296]
Contained in the anesthesia kit is a y-elbow part that connects the tubing and the mask together. The very beginning of a surgical procedure, the y-elbow that connects to the mask leaked when under pressure. No pt injury occurred.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1055236-2000-00003 |
| MDR Report Key | 266274 |
| Report Source | 00,06 |
| Date Received | 2000-02-25 |
| Date of Report | 2000-02-23 |
| Date of Event | 2000-01-27 |
| Date Facility Aware | 2000-01-27 |
| Report Date | 2000-02-23 |
| Date Mfgr Received | 2000-01-27 |
| Date Added to Maude | 2000-03-02 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Street | 200 DEBUSK LANE |
| Manufacturer City | POWELL TN 37849 |
| Manufacturer Country | US |
| Manufacturer Postal | 37849 |
| Manufacturer Phone | 4239387828 |
| 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 | 86-000790 ANESTHESIA KIT-BELLIN MEMORIAL |
| Generic Name | 7F1 ANESTHESIA KITS |
| Product Code | CCI |
| Date Received | 2000-02-25 |
| Model Number | * |
| Catalog Number | KIT # 86-000790 |
| Lot Number | 63969 |
| ID Number | ELBOW PART # 74-3010406C |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | UNKNOWN |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 257775 |
| Manufacturer | DEROYAL |
| Manufacturer Address | 200 DEBUSK LANE POWELL TN 37849 US |
| Baseline Brand Name | 86-000790 ANESTHESIA KIT-BELLIN MEMORIAL |
| Baseline Generic Name | 7F1 ANESTHESIA KITS |
| Baseline Model No | * |
| Baseline Catalog No | KIT # 86-000790 |
| Baseline ID | ELBOW PART # 74 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2000-02-25 |