MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-04-03 for HEPARNIO PRE-FILLED SYRINGES manufactured by Unk.
[104470249]
Patient presented to our ed on (b)(6) 2018 with fever and sepsis. He had blood cultures drawn which grew serratia marcescens. Patient was admitted for iv antibiotics and close monitoring. Patient recovered and was discharged (b)(6). Therapy start date: (b)(6) 2018. Therapy end date: (b)(6) 2018. Diagnosis or reason for use: heplock of central venous catheter (mediport) upon deaccess.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5076314 |
| MDR Report Key | 7395547 |
| Date Received | 2018-04-03 |
| Date of Report | 2018-03-30 |
| Date of Event | 2018-03-23 |
| Date Added to Maude | 2018-04-04 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| 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 | 0 |
| Brand Name | HEPARNIO PRE-FILLED SYRINGES |
| Generic Name | SYRINGE |
| Product Code | EJI |
| Date Received | 2018-04-03 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | UNK |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Other | 2018-04-03 |