MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2015-12-04 for CANNULA, COHEN 8378.00M 8378.00 manufactured by Richard Wolf Medical Instruments Corp (rwmic).
[32748289]
Actual device was returned for investigation on 10/30/2015. Facility indicated package was opened and end of device fell off. Device never used on patient. Rwmic received device, with tip off, and upon visual inspection found a small amount of solder. Amount of solder was insufficient in order to maintain an intact device during normal use. Manufacturing records revealed one individual performed the soldering step for this device lot. Manufacturing instructions to be reviewed with individual to assure manufacturing steps are clearly understood. Remaining inventory to be visually inspected as well as stress tested to verify sufficient amount of solder used on any remaining devices. Two similar issues have occured (mdr1418479-2015-00041 and mdr1418479-2015-00042). Rwmic considers this report closed.
Patient Sequence No: 1, Text Type: N, H10
[32748290]
Facility reported to richard wolf medical instrumentation corporation (rwmic) an attachment was placed on end of device then the tip of device fell off, out of box failure. Device in question was never used on a patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1418479-2015-00043 |
| MDR Report Key | 5268226 |
| Report Source | USER FACILITY |
| Date Received | 2015-12-04 |
| Date of Report | 2015-10-27 |
| Date of Event | 2015-10-27 |
| Date Mfgr Received | 2015-11-05 |
| Device Manufacturer Date | 2015-05-01 |
| Date Added to Maude | 2015-12-04 |
| 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 | SERVICE PERSONNEL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS DAWN CLARK |
| Manufacturer Street | 353 CORPORTATE WOODS PARKWAY |
| Manufacturer City | VERNON HILLS IL 600613110 |
| Manufacturer Country | US |
| Manufacturer Postal | 600613110 |
| Manufacturer Phone | 8003239653 |
| Manufacturer G1 | RICHARD WOLF MEDICAL INSTRUMENTS CORP (RWMIC) |
| Manufacturer Street | 353 CORPORTATE WOODS PARKWAY |
| Manufacturer City | VERNON HILLS IL 600613110 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 600613110 |
| Single Use | 3 |
| Remedial Action | IN |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CANNULA, COHEN |
| Generic Name | CANNULA |
| Product Code | HHI |
| Date Received | 2015-12-04 |
| Returned To Mfg | 2015-10-30 |
| Model Number | 8378.00M |
| Catalog Number | 8378.00 |
| Lot Number | 51003943 |
| Operator | SERVICE PERSONNEL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | RICHARD WOLF MEDICAL INSTRUMENTS CORP (RWMIC) |
| Manufacturer Address | 353 CORPORTATE WOODS PARKWAY VERNON HILLS IL 600613110 US 600613110 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-12-04 |