MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2006-08-09 for PRO-VENT PLUS ARTERIAL BLOOD SAMPLING KIT 46989-1 manufactured by Smiths Medical Asd, Inc..
[527226]
User alleges one event of receiving a contaminated needle stick. They reported that when they went to engage the needle into the protection it would not engage. No treatment.
Patient Sequence No: 1, Text Type: D, B5
[7834322]
Results evaluation codes: the user facility did not save any of the samples or record the lot number of the unit involved with this event. The investigation is limited to a review for the same type of event of not being able to engage the needle into the needle protection due to a manufacturing fault. A search of the complaints database show no similar reports on the catalog number and no similar reports on the needle protection component. Without the actual sample we are unable to determine te cause of this event. Due to no similar report we feel this was an isolated event.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1217052-2006-00048 |
| MDR Report Key | 764899 |
| Report Source | 05,06 |
| Date Received | 2006-08-09 |
| Date of Report | 2006-07-14 |
| Date of Event | 2006-05-26 |
| Date Mfgr Received | 2006-07-14 |
| Date Added to Maude | 2006-09-28 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Contact | TIMOTHY MATSON |
| Manufacturer Street | * |
| Manufacturer City | KEENE NH 03431 |
| Manufacturer Country | US |
| Manufacturer Postal | 03431 |
| Manufacturer Phone | 6033523812 |
| Manufacturer G1 | SMITHS MEDICAL ASD, INC |
| Manufacturer Street | * |
| 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 | TRAY, BLOOD COLLECTION |
| Product Code | GJE |
| Date Received | 2006-08-09 |
| Model Number | NA |
| Catalog Number | 46989-1 |
| Lot Number | UNK |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 752753 |
| Manufacturer | SMITHS MEDICAL ASD, INC. |
| Manufacturer Address | 10 BOWMAN DR. KEENE NH 03431 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2006-08-09 |