MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-12-15 for NEOCONNECT ORAL / ENTERAL SYRINGE NM-S35NC manufactured by Neomed, Inc..
[94957217]
Patient Sequence No: 1, Text Type: N, H10
[94957218]
Nurse received 35 ml enteral feeding syringe from the infant formula room. Rn found sealing cap difficult to remove. While trying to twist cap from syringe barrel, the syringe connector snapped off of the syringe barrel. The nurse transferred the breast milk to another syringe and proceeded with the feeding. Damaged syringe removed and sent to biomedical for evaluation. Manufacturer response for enteral syringe, enfit compliant, neoconnect (per site reporter): awaiting response.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 7120463 |
| MDR Report Key | 7120463 |
| Date Received | 2017-12-15 |
| Date of Report | 2017-12-12 |
| Date of Event | 2017-11-15 |
| Report Date | 2017-12-12 |
| Date Reported to FDA | 2017-12-12 |
| Date Reported to Mfgr | 2017-12-12 |
| Date Added to Maude | 2017-12-15 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | BIOMEDICAL ENGINEER |
| 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 ORAL / ENTERAL SYRINGE |
| Generic Name | ENTERAL SYRINGES WITH ENTERAL SPECIFIC CONNECTORS |
| Product Code | PNR |
| Date Received | 2017-12-15 |
| Model Number | NM-S35NC |
| Catalog Number | NM-S35NC |
| Operator | NURSE |
| Device Availability | * |
| Device Age | 1 DY |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | NEOMED, INC. |
| Manufacturer Address | 100 LONDONDERRY COURT SUITE 112 WOODSTOCK GA 30188 US 30188 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-12-15 |