MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a other,user facility report with the FDA on 2019-02-27 for 0.5ML NEOCONNECT PHARMACY SYRINGE, NON-STERILE manufactured by Neomed, Inc.
[138253310]
Sus voluntary event report number mw5082682 stated this has caused adverse events, however, did not document the detail of any adverse events. To date, neomed has not be able to identify the reporting facility based on the information provided in report number mw5082682. We contacted facilities our "senior engineer" visited in (b)(6) of 2018. All facilities contacted stated they did not file this sus voluntary event report. Neomed does not have any additional information pertaining to report number mw5082682.
Patient Sequence No: 1, Text Type: N, H10
[138253311]
Complaint reported via sus voluntary event report number mw5082682, received via (b)(6) from fda on (b)(6) 2019. No initial reporter information provided. Report stated 0. 5ml enfit syringes had been observed with a displacement of fluid syringe contents after placing the neomed syringe tip cap onto the syringe.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3006520777-2019-00001 |
| MDR Report Key | 8374550 |
| Report Source | OTHER,USER FACILITY |
| Date Received | 2019-02-27 |
| Date of Report | 2019-02-25 |
| Report Date | 2018-12-28 |
| Date Reported to FDA | 2018-12-28 |
| Date Mfgr Received | 2019-01-28 |
| Date Added to Maude | 2019-02-27 |
| 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 | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MRS. MELINDA SMITH |
| Manufacturer Street | 100 LONDONDERRY COURT SUITE 112 |
| Manufacturer City | WOODSTOCK 30188 |
| Manufacturer Country | US |
| Manufacturer Postal | 30188 |
| Manufacturer Phone | 7704855188 |
| Manufacturer G1 | SYNECCO, CO., LTD. |
| Manufacturer Street | B801 RONGAN PLAZA, NO. 700 SOUTH TIANTONG ROAD |
| Manufacturer City | YINZHOU DISTRICT, NINGBO 315100 |
| Manufacturer Country | CH |
| Manufacturer Postal Code | 315100 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | 0.5ML NEOCONNECT PHARMACY SYRINGE, NON-STERILE |
| Generic Name | ENTERAL SYRINGES WITH ENTERAL SPECIFIC CONNECTORS |
| Product Code | PNR |
| Date Received | 2019-02-27 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | NEOMED, INC |
| Manufacturer Address | 100 LONDONDERRY COURT SUITE 112 WOODSTOCK, GA GA 30188 US 30188 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-02-27 |