MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-02-28 for INJ. OPTIV DH, W/OEM 844007 manufactured by Liebel-flarsheim.
[102078242]
After saline injection the catheter is removed and the customer is stating residual pressure is present and saline and bodily fluids are released on 2 separate occurrences the bodily fluid and saline has then come into contact with the eye of the staff. Residual pressure build up; using y tubing; catheter size nexiva catheters 22 and 20 gauge; manufacturer of syringes: guerbet ultraject saline and optiray 320 125 ml prefilled contrast. Follow up information received on 28 february 2018 from the reporter, procedure being performed was abdominal/pelvic ct. Incident occurred when removing the tubing from the iv. As corrective treatment, the staff member received an eye flush at an eye wash station and had a blood draw for a baseline study. The patient was also requested to come in and have this done at a later date, but to date she has not done this. Nothing was found for the staff member's blood work. A potential user error is not excluded while disconnecting (tubing not clamped, abnormal disconnection method, or other issues) but an "injector contribution" to the event cannot be excluded.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1518293-2018-00005 |
| MDR Report Key | 7303422 |
| Date Received | 2018-02-28 |
| Date of Report | 2018-01-31 |
| Date of Event | 2018-01-31 |
| Date Mfgr Received | 2018-01-31 |
| Device Manufacturer Date | 2011-01-31 |
| Date Added to Maude | 2018-02-28 |
| 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 | RADIOLOGIC TECHNOLOGIST |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | FRED RECKELHOFF |
| Manufacturer Street | 2111 E. GALBRAITH RD |
| Manufacturer City | CINCINNATI OH 45237 |
| Manufacturer Country | US |
| Manufacturer Postal | 45237 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | INJ. OPTIV DH, W/OEM |
| Generic Name | INJ. OPTIV DH, W/OEM |
| Product Code | IZQ |
| Date Received | 2018-02-28 |
| Model Number | 844007 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | LIEBEL-FLARSHEIM |
| Manufacturer Address | 2111 E. GALBRAITH RD CINCINNATI OH 45237 US 45237 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-02-28 |