MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2008-01-17 for PRO-VENT PLUS ARTERIAL BLOOD SAMPLING KIT G1460J manufactured by Smiths Medical Asd, Inc..
[17371955]
User alleges one event of when performed a blood draw and, when went to engage the needle, the needle could not click into the needle protection device. Needle stick reported. No treatment.
Patient Sequence No: 1, Text Type: D, B5
[17543577]
Results evaluation (other): our investigation into this event is very limited as the user facility did not return the device 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 further review shows no similar reports received on this catalog number. A review of the mfg and incoming records show no problems noted that would explain this event. The mfg lot size, for the reported lot number, was 53,300 units. Without the device sample we are unable to determine the exact cause of this event. Due to no similar reports received, we feel this is an isolated incident and it has been logged for trending.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1217052-2008-00015 |
| MDR Report Key | 981141 |
| Report Source | 07 |
| Date Received | 2008-01-17 |
| Date of Report | 2007-12-26 |
| Date of Event | 2007-12-25 |
| Date Mfgr Received | 2007-12-26 |
| Device Manufacturer Date | 2007-05-01 |
| Date Added to Maude | 2008-07-22 |
| 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 | 0 |
| Manufacturer Contact | TIMOTHY MATSON |
| Manufacturer Street | 10 BOWMAN DR. |
| Manufacturer City | KEENE NH 03431 |
| Manufacturer Country | US |
| Manufacturer Postal | 03431 |
| Manufacturer Phone | 6033523812 |
| Manufacturer G1 | SMITHS MEDICAL ASD, INC. |
| Manufacturer City | KEENE NH 03431 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 03431 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PRO-VENT PLUS ARTERIAL BLOOD SAMPLING KIT |
| Generic Name | 75 GJE- TRAY, BLOOD COLLECTION |
| Product Code | GJE |
| Date Received | 2008-01-17 |
| Catalog Number | G1460J |
| Lot Number | 1157891 |
| Device Expiration Date | 2010-04-01 |
| 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 | 985109 |
| Manufacturer | SMITHS MEDICAL ASD, INC. |
| Manufacturer Address | 10 BOWMAN DR. KEENE NH 03431 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2008-01-17 |