MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2007-10-30 for ANAEROBIC PULSATORT PLUS ARTERIAL BLOOD SAMPLING KIT 4058NP-2 manufactured by Smiths Medical Asd, Inc..
[709041]
User alleges two events of blood spray into the eyes due to snapping the needle into the needle protection, causing the blood to spray. No treatment reported.
Patient Sequence No: 1, Text Type: D, B5
[7882803]
Results evaluations codes: our investigation into this event is very limited as the user facility did not retain the needle used in this event. A review of our complaints database show no other reports on this device lot number of the finished good or the needle lot number. A review of the labeling reveals this issue is identified in our instructions for use: a review of the instructions for use reveals: and a work step "after procedure is completed, press the needle into the sheath using a one-handed technique by gently pressing the sheath against a flat surface. " no corrective action has been assigned as this event is likely due to user error. This report has been logged for trending purposes.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1217052-2007-00137 |
| MDR Report Key | 934916 |
| Report Source | 07 |
| Date Received | 2007-10-30 |
| Date of Report | 2007-10-02 |
| Date Mfgr Received | 2007-10-02 |
| Date Added to Maude | 2007-12-20 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | TIMOTHY MASON |
| Manufacturer City | KEENE NH 03431 |
| Manufacturer Postal | 03431 |
| Manufacturer Phone | 6033523812 |
| Manufacturer G1 | SMITHS MEDICAL ASD, INC. |
| Manufacturer City | KEENE NH 03431 |
| Manufacturer Postal Code | 03431 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ANAEROBIC PULSATORT PLUS ARTERIAL BLOOD SAMPLING KIT |
| Generic Name | 75 GJE - TRAY, BLOOD COLLECTION |
| Product Code | GJE |
| Date Received | 2007-10-30 |
| Catalog Number | 4058NP-2 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 932766 |
| Manufacturer | SMITHS MEDICAL ASD, INC. |
| Manufacturer Address | 10 BOWMAN DR. KEENE NH 03431 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2007-10-30 |