MAUDE Adverse Event Report: CAREFUSION 2200, INC. V. MUELLER HARTMAN CURVED FORCEPS DELICATE; CLAMP, VASCULAR

Model Number VM25-2385

Device Problem Break (1069)

Patient Problem No Information (3190)

Event Date 10/20/2016

Event Type  malfunction  

Event Description

Tip of mosquito clamp broke off.It was discovered after the case.

• Brand Name: V. MUELLER HARTMAN CURVED FORCEPS DELICATE
• Type of Device: CLAMP, VASCULAR
• Manufacturer (Section D): CAREFUSION 2200, INC.; 75 n. fairway drive; vernon hills IL 60061
• MDR Report Key: 6092135
• MDR Text Key: 59581914
• Report Number: 6092135
• Device Sequence Number: 1
• Product Code: GEN
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/08/2016

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: No Information
• Device Model Number: VM25-2385
• Device Catalogue Number: VM25-2385
• Device Lot Number: 100312
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/08/2016
• Event Location: Hospital
• Date Report to Manufacturer: 11/08/2016
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/10/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 5 YR