MAUDE Adverse Event Report: INTEGRA LIFESCIENCES PRODUCTION CORPORATION INTEGRA JARIT; HEMOSTAT

Model Number 105-089

Device Problems Break (1069); Component Missing (2306)

Patient Problem Insufficient Information (4580)

Event Date 03/04/2021

Event Type  malfunction  

Event Description

During vascular procedure, approximately 3mm tip of jacobsen mosquito clamp broke off.Tip was initially retrieved but then lost.

• Brand Name: INTEGRA JARIT
• Type of Device: HEMOSTAT
• Manufacturer (Section D): INTEGRA LIFESCIENCES PRODUCTION CORPORATION; 11 cabot blvd.; mansfield MA 02048
• MDR Report Key: 11526620
• MDR Text Key: 241006006
• Report Number: 11526620
• 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: Nurse
• Type of Report: Initial
• Report Date: 03/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/19/2021
• 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: 105089
• Device Lot Number: 1002181403
• 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: 03/16/2021
• Date Report to Manufacturer: 03/19/2021
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 24820 DA