MAUDE Adverse Event Report: CAREFUSION HALSTED MOSQUITO FORCEPS 5IN CVD; CLAMP, VASCULAR

Model Number SU2702 - HALSTED MOSQUITO FORCEPS 5IN CVD

Device Problem Break (1069)

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

Event Date 01/08/2015

Event Type  malfunction  

Event Description

Medical specialties - broken report stated "mosquito clamp broke during procedure, all pieces retrieved.What was the original intended procedure? transcatheter aortic valve replacement.Device usage problem: device failed (e.G.Broke, couldn't get it to work or stopped working). male, (b)(6) years, weight (b)(6)." sample is available.Lot number unknown.

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.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: HALSTED MOSQUITO FORCEPS 5IN CVD
• Type of Device: CLAMP, VASCULAR
• 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: 4554445
• MDR Text Key: 5461649
• Report Number: 1423507-2015-00027
• 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: Health Professional
• Type of Report: Initial

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: Health Professional
• Device Model Number: SU2702 - HALSTED MOSQUITO FORCEPS 5IN CVD
• Device Catalogue Number: SU2702
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/12/2015
• Initial Date FDA Received: 02/27/2015
• 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 Age: 74 YR
• Patient Weight: 82