MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2006-09-12 for SAF-T HOLDER BLOOD CULTURE DEVICE WITH MALE LUER 96004 manufactured by Smiths Medical Asd, Inc..
[16833960]
User alleges clinician received a needle stick when trying to push a saf-t holder into a full sharp container. The flap of the sharps container would not swing. The clinician was trying to push the unit through and when trying to push the unit in was stuck on the finger with the back-end needle. Treatment was given.
Patient Sequence No: 1, Text Type: D, B5
[16962683]
Results evaluation: smiths medical asd, inc. Is unable to fully evaluate this report. There has been no lot number or sample given for evaluation. A review of manufacturing records cannot be performed due to the insufficient information. A review of device labeling states: 6. 3 after use, place sharps in a suitable sharps container. Dispose of contaminated product in a safe manner according to centers for disease control and prevention, usa and federal/state/local regulations (epa, osha) and health care facility guidelines or local equivalent.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1217052-2006-00074 |
| MDR Report Key | 759672 |
| Report Source | 07 |
| Date Received | 2006-09-12 |
| Date of Report | 2006-09-01 |
| Date of Event | 2006-08-01 |
| Date Mfgr Received | 2006-09-01 |
| Date Added to Maude | 2006-09-14 |
| 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 | SAF-T HOLDER BLOOD CULTURE DEVICE WITH MALE LUER |
| Generic Name | TRAY, BLOOD COLLECTION |
| Product Code | GJE |
| Date Received | 2006-09-12 |
| Model Number | NA |
| Catalog Number | 96004 |
| Lot Number | NI |
| ID Number | NA |
| 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 | 747590 |
| Manufacturer | SMITHS MEDICAL ASD, INC. |
| Manufacturer Address | 10 BOWMAN DR. KEENE NH 03431 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2006-09-12 |