MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-05-08 for HEPARIN I.V. FLUSH SYRINGE; 100 UNITS/ML MIH-3323 manufactured by Medefil, Inc..
[108167938]
Currently under investigation capa#(b)(4).
Patient Sequence No: 1, Text Type: N, H10
[108167939]
(b)(6), reported that they found 5 syringes without labels of heparin i. V flush syringe, lot #h118108n (3 ml in 6 ml syrigne). The syringes are packed in a dispenser and have the outer pouch intact.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1423982-2018-00001 |
| MDR Report Key | 7496837 |
| Date Received | 2018-05-08 |
| Date of Report | 2018-05-08 |
| Date of Event | 2018-05-05 |
| Date Mfgr Received | 2018-05-05 |
| Device Manufacturer Date | 2018-01-08 |
| Date Added to Maude | 2018-05-08 |
| 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 |
| Reporter Occupation | PHARMACIST |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. PRADEEP AGGARWAL |
| Manufacturer Street | 405 WINDY POINT DRIVE GLENDALE HEIGHTS |
| Manufacturer City | IL 60139 |
| Manufacturer Country | US |
| Manufacturer Postal | 60139 |
| Manufacturer Phone | 6306814600 |
| Manufacturer G1 | MEDEFIL, INC. |
| Manufacturer Street | 250 WINDY POINT DRIVE GLENDALE HEIGHTS |
| Manufacturer City | IL 60139 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 60139 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | HEPARIN I.V. FLUSH SYRINGE; 100 UNITS/ML |
| Generic Name | HEPARIN I.V FLUSH SYRINGE |
| Product Code | NZW |
| Date Received | 2018-05-08 |
| Catalog Number | MIH-3323 |
| Lot Number | H118108N |
| Device Expiration Date | 2019-01-12 |
| Operator | PHARMACIST |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDEFIL, INC. |
| Manufacturer Address | 405 WINDY POINT DRIVE GLENDALE HEIGHTS,, IL 60139 US 60139 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-05-08 |