MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06,08 report with the FDA on 2007-05-29 for BIG (BONE INJECTION GUN) ADULT MODEL WMBIGA1 manufactured by Waismed Ltd.
[2912472]
Paramedic on site stated that during treatment of a pt in cardiac arrest, vein line attempts failed therefore he decided to establish an io line. Customer reported that when opening the device package, the needle was not attached (was loose) fell out of package prior to use. Device was never used on pt.
Patient Sequence No: 1, Text Type: D, B5
[10139648]
Customer contacted distributor (b)(6) 2007 to report device failure. Distributor contacted manufacturer (b)(6) 2007. Waismed has been trying to recreate by many different tests and analysis. We have investigated packaging, extreme handling, drop tests, original assembly designs. All of these are being looked at to see if failure can be recreated. We have not recreated needle falling out. However, we are working to improve packaging since paramedics handling can be rough. New packaging samples have been ordered to see if the package can be an improvement. Review of internal needle holding mechanism has been checked and the assembly process reviewed. Increased finished goods qc checks have been implemented. We have recommended to the customer to carry two devices as backup since customer stated they did not have second unit in their bag. Customer has implemented new protocol to have various backup equipment for io access.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9616791-2007-00001 |
| MDR Report Key | 2760119 |
| Report Source | 06,08 |
| Date Received | 2007-05-29 |
| Date of Report | 2007-05-15 |
| Date of Event | 2007-02-02 |
| Date Mfgr Received | 2007-04-15 |
| Device Manufacturer Date | 2004-10-01 |
| Date Added to Maude | 2012-09-28 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Street | HANATRAN 3 |
| Manufacturer City | KIRYAT GAT 32000 |
| Manufacturer Country | IS |
| Manufacturer Postal | 32000 |
| Manufacturer Phone | 9729955021 |
| Single Use | 3 |
| Remedial Action | RL |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BIG (BONE INJECTION GUN) ADULT MODEL |
| Generic Name | INTRAOSSEOUS DEVICE |
| Product Code | MHC |
| Date Received | 2007-05-29 |
| Returned To Mfg | 2007-04-25 |
| Model Number | WMBIGA1 |
| Lot Number | 103 |
| Device Expiration Date | 2007-10-10 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | WAISMED LTD |
| Manufacturer Address | HERTZLIYA IS |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2007-05-29 |