MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2005-01-19 for FLEXIFLO ENTERAL FEEDING TUBE 473 NA manufactured by Ross Products Division, Abbott Laboratories.
[392631]
Stylet punctured through the tube wall. During placement, the nurse had difficulty ausculating. And x-ray was done. Reporter stated the x-ray showed the stylet had punctured the tube. Reporter also stated the stylet had not been removed from the tube and reinserted during the procedure. There was no report of patient injury resulting from the event.
Patient Sequence No: 1, Text Type: D, B5
[6084084]
Stylet punctured through the tube wall. During placement, the nurse had difficulty auscultating. An x-ray was done. Reporter stated the x-ray showed the stylet had punctured the tube. Reporter also stated the stylet had not been removed from the tube and reinserted during the procedure. There was no report of patient injury resulting from the event.
Patient Sequence No: 2, Text Type: D, B5
| Report Number | 1528738-2005-00003 |
| MDR Report Key | 571115 |
| Report Source | 06 |
| Date Received | 2005-01-19 |
| Date of Report | 2005-01-14 |
| Date of Event | 2004-12-14 |
| Date Mfgr Received | 2005-01-14 |
| Device Manufacturer Date | 2004-07-01 |
| Date Added to Maude | 2005-02-09 |
| 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 | DANIEL HAMILTON |
| Manufacturer Street | 625 CLEVELAND AVENUE |
| Manufacturer City | COLUMBUS OH 43215 |
| Manufacturer Country | US |
| Manufacturer Postal | 43215 |
| Manufacturer Phone | 6146243743 |
| Manufacturer G1 | * |
| Manufacturer Street | 16 ABBOTT LABORATORIES |
| Manufacturer City | COLUMBUS OH * |
| Manufacturer Country | US |
| Manufacturer Postal Code | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | FLEXIFLO ENTERAL FEEDING TUBE |
| Generic Name | 78 BSS TUBE, NASOGASTRIC |
| Product Code | BSS |
| Date Received | 2005-01-19 |
| Returned To Mfg | 2004-12-20 |
| Model Number | 473 |
| Catalog Number | NA |
| Lot Number | 19-249-GD |
| ID Number | 510(K) K992494 |
| Device Expiration Date | 2007-06-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 560965 |
| Manufacturer | ROSS PRODUCTS DIVISION, ABBOTT LABORATORIES |
| Manufacturer Address | 625 CLEVELAND AVENUE COLUMBUS OH 43215 US |
| Baseline Brand Name | FLEXIFLO ENTERAL FEEDING TUBE (8 FRENCH, 45" WITH STYLET) |
| Baseline Generic Name | NASOGASTRIC FEEDING TUBE |
| Baseline Model No | 473 |
| Baseline Catalog No | NA |
| Baseline ID | NA |
| Baseline Device Family | K039 |
| Baseline Shelf Life Contained | Y |
| Baseline Shelf Life [Months] | 36 |
| Baseline PMA Flag | N |
| Baseline 510K PMN | Y |
| Premarket Notification | K992494 |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2005-01-19 |
| 2 | 0 | 2005-01-19 |