MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-11-13 for NEOCONNECT PNM-S12NC manufactured by Neomed, Inc.
[126911577]
A neoconnect oral enteral syringe with enfit connector was obtained in order to deliver oral/enteral medication to an infant. It was noted when the packaging was opened that it was not an enfit connector that was in the package. It was a straight tip connector. Another syringe was obtained and it had an enfit tip. The packaging of both of these syringes had the exact same reference and lot numbers and were labeled the same. The straight tip connector is not one that we use in our facility because it can inadvertently be connected to an iv catheter and increase the potential of an oral medication/feed being entered into an iv. Fortunately, this did not reach the patient and the nurse stopped when she noticed the catheter tip was not compatible with the enfit system.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8063599 |
| MDR Report Key | 8063599 |
| Date Received | 2018-11-13 |
| Date of Report | 2018-11-08 |
| Date of Event | 2018-11-08 |
| Report Date | 2018-11-08 |
| Date Reported to FDA | 2018-11-08 |
| Date Reported to Mfgr | 2018-11-13 |
| Date Added to Maude | 2018-11-13 |
| 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 | 0 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | NEOCONNECT |
| Generic Name | SYRINGE, ENTERAL |
| Product Code | PNR |
| Date Received | 2018-11-13 |
| Returned To Mfg | 2018-11-09 |
| Model Number | PNM-S12NC |
| Catalog Number | PNM-S12NC |
| Lot Number | 20171110 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | 0 YR |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | NEOMED, INC |
| Manufacturer Address | 100 LONDONDERRY CT. SUITE 112 WOODSTOCK GA 30188 US 30188 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-11-13 |