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

Model Number	830209
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/28/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A full investigation could not be completed, as the actual device was not returned to the richard wolf facility.However, a photo of broke device was submitted for review.Photo showed a bowed shaft and the distal end of cannula was missing.Bowing of the shaft is due to excessive force applied.If excessive axial force, greater than 50lb/f (foot pounds) is applied, the cannula tip will break.Device manufactured date - sep2006.Device purchased date - a total of three cannulas (lot #249s06) were purchased by user facility: 25sep2006, 04oct2006, 02nov2006.Service dates - no entries of service performed.No similar complaint have occurred in the last three years on this device type.Richard wolf considers this matter closed.However, in the event the device is returned or additional information is received, rwmic will provide fda with a follow-up report.
Event or Problem Description
User facility notified richard wolf medical instruments corporation (rwmic) that after removing cannula from patient during a procedure, it was noticed the cannula was broken.According to user facility, cannula broke approximately one inch from distal end.A similar back up device was available for use and procedure completed as scheduled.After procedure was completed, x-ray was performed on patient to ensure no foreign objects remained.No injury to patient or staff reported.
Additional Manufacturer Narrative
Follow up #1, the following information was updated / completed: additional: patient information.Corrected / changed /required by missing data report : describe event or problem, common device name (fda product code), contact office information, date received by mfr., type of report, type of reportable event, if follow-up, what type? additional manufacturer narrative and/or corrected data.Richard wolf medical instruments corporation (rwmic) received information from the user facility on november 13, 2017.Richard wolf medical instruments corporation (rwmic) considers this matter closed.However, in the event rwmic receives any additional information a follow up report will be submitted to fda.
Event or Problem Description
Follow up report #1.

• Brand Name: CANNULA
• Common Device Name: CANNULA
• Manufacturer (Section D): RICHARD WOLF MEDICAL INSTRUMENTS CORP (RWMIC); registration #1418479; 353 corporate woods parkway; vernon hills IL 60061 3110
• MDR Report Key: 7023243
• Report Number: 1418479-2017-00031
• Device Sequence Number: 11042485
• Product Code: HRX
• UDI-Device Identifier: 04055207039762
• UDI-Public: 04055207039762
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 10/16/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Physician
• Device Model Number: 830209
• Device Catalogue Number: 8302.09
• Device Lot Number: 249S06
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 10/16/2017
• Supplement Date Received by Manufacturer: 11/13/2017
• Initial Report FDA Received Date: 11/10/2017
• Supplement Report FDA Received Date: 11/28/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 29 YR
• Patient Weight: 58