MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2012-03-09 for N-PAK * BAK-02 manufactured by M-pro.
[14926518]
Nurse in room to perform rsv test with nasopharyngeal aspiration kit. The tip of the tube came off in patient's left nare when the baby was crying, which resulted in the tubing being sucked in the patient's nose. A doctor attempted to get it out. Multiple attempts were unsuccessful. Another doctor called into retrieve tip and was successful. The tube was removed intact and there was no harm done to the patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2502115 |
| MDR Report Key | 2502115 |
| Date Received | 2012-03-09 |
| Date of Report | 2012-03-09 |
| Date of Event | 2012-02-16 |
| Report Date | 2012-03-09 |
| Date Reported to FDA | 2012-03-09 |
| Date Added to Maude | 2012-03-23 |
| 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 | N-PAK |
| Generic Name | CATHETER, NASOPHARYNGEAL |
| Product Code | ENW |
| Date Received | 2012-03-09 |
| Model Number | * |
| Catalog Number | BAK-02 |
| Lot Number | 042229409 |
| ID Number | * |
| Operator | NURSE |
| Device Age | 1 DY |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | M-PRO |
| Manufacturer Address | 840 NORWAY DRIVE ANNANDALE MN 55302 US 55302 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2012-03-09 |