MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2018-01-04 for PRO-VENT PLUS, 3CC LL SYRINGE, 23G X 1IN NDLE, FILTER+ EDGE 4558PG manufactured by Smiths Medical, Asd, Inc..
[96360949]
It was reported that after having performed a blood gas analysis using a pro-vent plus, 3cc ll syringe, 23g x 1in ndle, filter+ edge, the nurse fixed the filter pro device and then slowly pushed the plunger to release the air bubbles. All of the blood came out of the syringe dirtying the nurses in the face and eyes. The staff were exposed to contaminated blood. No other information was provided to indicate any other adverse events or medical interventions.
Patient Sequence No: 1, Text Type: D, B5
[109255519]
Patient Sequence No: 1, Text Type: N, H10
[109255520]
It was reported there was no additional injury as a result of the event. In response to the blood exposure, the event was reported to the emergency department. The result of the event was reported as ongoing.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3012307300-2018-00028 |
| MDR Report Key | 7164042 |
| Report Source | USER FACILITY |
| Date Received | 2018-01-04 |
| Date of Report | 2018-02-12 |
| Date of Event | 2017-11-17 |
| Date Mfgr Received | 2018-01-29 |
| Device Manufacturer Date | 2017-07-05 |
| Date Added to Maude | 2018-01-04 |
| 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 | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | DAVE HALVERSON |
| Manufacturer Street | 6000 NATHAN LANE NORTH |
| Manufacturer City | MINNEAPOLIS MN 55442 |
| Manufacturer Country | US |
| Manufacturer Postal | 55442 |
| Manufacturer Phone | 7633833310 |
| Manufacturer G1 | SMITHS MEDICAL NORTH AMERICA |
| Manufacturer Street | 10 BOWMAN DRIVE |
| Manufacturer City | KEENE NH 034310724 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 034310724 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PRO-VENT PLUS, 3CC LL SYRINGE, 23G X 1IN NDLE, FILTER+ EDGE |
| Generic Name | BLOOD SPECIMEN COLLECTION KIT (EXCLUDES HIV TESTING) |
| Product Code | OFZ |
| Date Received | 2018-01-04 |
| Catalog Number | 4558PG |
| Lot Number | 3443002 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SMITHS MEDICAL, ASD, INC. |
| Manufacturer Address | 6000 NATHAN LANE NORTH MINNEAPOLIS MN 55442 US 55442 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2018-01-04 |