MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 1999-11-10 for CLAY ADAMS RUBBER CANTOR TUBE, PEDIATRIC SIZE, 12FR 427692 manufactured by Becton Dickinson.
[161016]
Bag with mercury separated from the tubing during internal use of the cantor tube with a pt. Bag and mercury expected to pass normally. No pt injury reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1119779-1999-00006 |
| MDR Report Key | 250487 |
| Report Source | 05 |
| Date Received | 1999-11-10 |
| Date of Report | 1999-10-15 |
| Date of Event | 1999-10-11 |
| Date Mfgr Received | 1999-10-15 |
| Date Added to Maude | 1999-11-22 |
| 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 | DAVID GATES |
| Manufacturer Street | 7 LOVETON CIRCLE |
| Manufacturer City | SPARKS MD 21152 |
| Manufacturer Country | US |
| Manufacturer Postal | 21152 |
| Manufacturer Phone | 4103164367 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CLAY ADAMS RUBBER CANTOR TUBE, PEDIATRIC SIZE, 12FR |
| Generic Name | GASTROINTESTINAL DECOMPRESSION DEVICE, CANTOR TUBE |
| Product Code | FEF |
| Date Received | 1999-11-10 |
| Model Number | NA |
| Catalog Number | 427692 |
| 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 | 242669 |
| Manufacturer | BECTON DICKINSON |
| Manufacturer Address | 7 LOVETON CIR. SPARKS MD 21152 US |
| Baseline Brand Name | CLAY ADAMS RUBBER CANTOR TUBE PEDIATRIC SIZE, 12FR |
| Baseline Generic Name | GASTROINTESTINAL DECOMPRESSION DEVICE |
| Baseline Model No | NA |
| Baseline Catalog No | 427692 |
| Baseline ID | NA |
| Baseline Device Family | GASTROINTESTINAL DECOMPRESSION DEVICE |
| Baseline Shelf Life [Months] | NA |
| Baseline PMA Flag | N |
| Baseline 510K PMN | N |
| Baseline Preamendment | Y |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1999-11-10 |