MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-05-27 for KANGAROO POLYURETHANE FEEDING TUBE * 461412 manufactured by Covidien.
[5842741]
The feeding tube was inserted in the premature infant on (b)(6), in the infant's right nare. On (b)(6), the infant's father was doing skin-to-skin contact with the infant while the tube feeding was continuously feeding the infant. The nurse disconnected the extension from the feeding tube to return the infant into the isolette. The nurse reported that she "did close the top piece. " as the infant's father rose up from the chair with the infant in his arms, the nurse notices that the feeding tube cap (purple)fell to the floor and the tube feeding began dripping onto the floor. The nurse assisted the father with positioning the infant back into the isolette. The nurse examined the feeding tube and removed it. A new feeding tube was reinserted. There were no adverse effects to the infant. Both the feeding tube and purple cap were retained and we would like to return this to the manufacturer for an inspection upon their request. The specific lot number for this device is unknown. However, all devices currently on the nursing unit are from the same lot, 509108064x.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 4826490 |
| MDR Report Key | 4826490 |
| Date Received | 2015-05-27 |
| Date of Report | 2015-05-27 |
| Date of Event | 2015-05-14 |
| Report Date | 2015-05-27 |
| Date Reported to FDA | 2015-05-27 |
| Date Reported to Mfgr | 2015-06-09 |
| Date Added to Maude | 2015-06-09 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | KANGAROO POLYURETHANE FEEDING TUBE |
| Generic Name | TUBE NASOGASTRIC FEEDING |
| Product Code | BSS |
| Date Received | 2015-05-27 |
| Model Number | * |
| Catalog Number | 461412 |
| Lot Number | * |
| ID Number | * |
| Device Availability | Y |
| Device Age | 6 DA |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COVIDIEN |
| Manufacturer Address | 15 HAMPSHIRE ST. MANSFIELD MA 02048 US 02048 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-05-27 |