MAUDE Adverse Event Report: CAREFUSION V. MUELLER BACKHAUS TOWEL FORCEPS 5-1/4IN; SU2905 - BACKHAUS TOWEL FORCEPS 5-1/4IN

Model Number SU2905

Device Problem Break (1069)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/25/2015

Event Type  malfunction  

Event Description

(b)(4) - broken med watch reported " while performing a left above-knee amputation, surgeon was using the towel clip as a bone retractor when the clip broke.Portion of the clip that  broke retrieved and no patient harm.Surgery was completed.What was the original intended procedure?, left above the knee amputation.Device usage problem: device failed ( e.G.Broke, couldn't get it to work or stopped working)." patient was a (b)(6) male. no requested action was specified.

Manufacturer Narrative

The reportable device has not been returned for an evaluation by the user facility and is not available for evaluation at this time.In addition, a device lot number is not available.A follow up was sent to the facility for return of the device and any additional information.Per the user facility response , "items involved with patient care which malfunction/break, etc.Are not allowed off site until any applicable statute of limitations has run, therefore the item will not be returned at this juncture.Having said that, once this equipment issue is properly identified, a representative from carefusion and/or cardinal health is welcome to make an appointment to examine the equipment on site." if the reportable device should become available for examination a follow up with additional information will be submitted thereafter with the results from any additional investigation.

• Brand Name: V. MUELLER BACKHAUS TOWEL FORCEPS 5-1/4IN
• Type of Device: SU2905 - BACKHAUS TOWEL FORCEPS 5-1/4IN
• Manufacturer (Section D): CAREFUSION; 75 north fairway drive; vernon hills IL 60061
• Manufacturer (Section G): CAREFUSION 2200, INC; 75 north fairway drive; vernon hills 60061
• Manufacturer Contact: jill rittorno ; 75 north fairway drive; vernon hills, IL 60061 ; 8473628056
• MDR Report Key: 4759226
• MDR Text Key: 16179109
• Report Number: 1423507-2015-00031
• Device Sequence Number: 1
• Product Code: GEN
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 05/08/2015

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
• Device Operator: Physician
• Device Model Number: SU2905
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/16/2015
• Initial Date FDA Received: 05/08/2015
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 57 YR