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

Model Number 106-222

Device Problem Break (1069)

Patient Problem No Code Available (3191)

Event Date 09/04/2019

Event Type  malfunction  

Event Description

During the procedure, when the radiologist was creating a pocket for the chest port, the curved hemostat broke underneath the skin.We were able to retrieve the whole piece of the instrument and took additional xrays to show proof of no instrument under the skin.

• Brand Name: INTEGRA JARIT
• Type of Device: HEMOSTAT
• Manufacturer (Section D): INTEGRA YORK PA, INC.; 589 davies dr; york PA 17402
• MDR Report Key: 9134074
• MDR Text Key: 160519227
• Report Number: 9134074
• 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: 09/18/2019,09/17/2019

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: Health Professional
• Device Model Number: 106-222
• Device Catalogue Number: 106222
• 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: 09/18/2019
• Date Report to Manufacturer: 09/30/2019
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/30/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 18615 DA