MAUDE Adverse Event Report: RICHARD WOLF MEDICAL INSTRUMENTS CORP (RWMIC) CANNULA, COHEN

Model Number 8378.00M

Device Problems Out-Of-Box Failure (2311); Solder Joint Fracture (2324)

Patient Problem No Patient Involvement (2645)

Event Date 10/26/2015

Event Type  malfunction  

Manufacturer Narrative

Actual device was returned for investigation on 09/22/2015.Device not being used on patient when issues occured.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.One similar issue has occured, mdr1418479-2015-00041.Rwmic considers this report closed.

Event Description

Facility reported to richard wolf medical instrumentation corporation (rwmic) the end of device fell off.Device in question not being used on a patient when issue discovered.

• Brand Name: CANNULA, COHEN
• Type of Device: CANNULA
• Manufacturer (Section D): RICHARD WOLF MEDICAL INSTRUMENTS CORP (RWMIC); 353 corportate woods parkway; vernon hills IL 60061 3110
• Manufacturer (Section G): RICHARD WOLF MEDICAL INSTRUMENTS CORP (RWMIC); 353 corportate woods parkway; vernon hills IL 60061 3110
• Manufacturer Contact: dawn clark ; 353 corportate woods parkway; vernon hills, IL 60061-3110 ; 8003239653
• MDR Report Key: 5268213
• MDR Text Key: 32722317
• Report Number: 1418479-2015-00042
• Device Sequence Number: 1
• Product Code: HHI
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Service Personnel
• Remedial Action: Inspection
• Type of Report: Initial
• Report Date: 10/26/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/04/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Service Personnel
• Device Model Number: 8378.00M
• Device Catalogue Number: 8378.00
• Device Lot Number: 51003943
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/22/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/05/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/01/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1