MAUDE Adverse Event Report: CARDINAL HEALTH 200, LLC ROCHESTER PEAN CURVED; HEMOSTAT

Model Number BN16-2800

Device Problem Break (1069)

Patient Problem Insufficient Information (4580)

Event Date 11/15/2021

Event Type  malfunction  

Event Description

Rochester pean curved forceps: tine broke while attempting to clamp a chest tube.New forceps obtained.

• Brand Name: ROCHESTER PEAN CURVED
• Type of Device: HEMOSTAT
• Manufacturer (Section D): CARDINAL HEALTH 200, LLC; 3651 birchwood drive; waukegan IL 60085
• MDR Report Key: 12843287
• MDR Text Key: 281012262
• Report Number: 12843287
• Device Sequence Number: 1
• Product Code: HRQ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/19/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: BN16-2800
• Device Catalogue Number: BJ16-2800
• Device Lot Number: 689572
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/16/2021
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 11/19/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 29200 DA
• Patient Sex: Male