MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ORISE¿ GEL; SUBMUCOSAL INJECTION AGENT

Model Number M00519200

Device Problem Break (1069)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/21/2022

Event Type  malfunction  

Event Description

Slip tip of orise 10 syringe broke off inside of connector port of injection needle.

• Brand Name: ORISE¿ GEL
• Type of Device: SUBMUCOSAL INJECTION AGENT
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 14041869
• MDR Text Key: 288798701
• Report Number: 14041869
• Device Sequence Number: 1
• Product Code: PLL
• 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: 03/22/2022

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 Model Number: M00519200
• Device Lot Number: 28495209
• 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: 03/22/2022
• Event Location: Hospital
• Date Report to Manufacturer: 04/07/2022
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/07/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 27740 DA
• Patient Sex: Female