MAUDE Adverse Event Report: INTEGRA YORK PA, INC. INTEGRA JARIT; HEMOSTAT

Model Number 105-089

Device Problems Break (1069); Device Fell (4014)

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

Event Date 07/31/2019

Event Type  malfunction  

Event Description

During scheduled pacemaker case, surgical tech grabbed hemostats and attempted to grab suture needle and was unable to obtain the needle.Upon looking at the hemostat, he noticed a small piece of the tip fell off the hemostat onto my sterile table.He then proceeded to complete the task without the hemostat and then removed the hemostat and broken tip from the sterile field.

• Brand Name: INTEGRA JARIT
• Type of Device: HEMOSTAT
• Manufacturer (Section D): INTEGRA YORK PA, INC.; 589 davies dr; york PA 17402
• MDR Report Key: 8959730
• MDR Text Key: 156439036
• Report Number: 8959730
• 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: Risk Manager
• Type of Report: Initial
• Report Date: 08/26/2019,08/13/2019

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: 105-089
• Device Catalogue Number: 108060-1407
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/26/2019
• Date Report to Manufacturer: 09/04/2019
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/04/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 30295 DA