MAUDE Adverse Event Report: BOSTON SCIENTIFIC SPOT ENDOSCOPIC MARKER; INJECTION NEEDLE CATHETER

Catalog Number M00518350

Device Problem Component Missing (2306)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/27/2015

Event Type  malfunction  

Event Description

Spot endoscopic marker needed for tatooing patient.The device used to inject tatoo ink did not have a needle.Two devices were opened and did not have a needle.Both devices had the same reference and lot number.A third device was opened with a different reference and lot number, and this device was used.No harm to the patient.

• Brand Name: SPOT ENDOSCOPIC MARKER
• Type of Device: INJECTION NEEDLE CATHETER
• Manufacturer (Section D): BOSTON SCIENTIFIC; 100 boston scientific way; marlborough MA 01752
• Manufacturer Contact: 300 boston scientific way; marlorough, MA 01752
• MDR Report Key: 5623589
• MDR Text Key: 44149232
• Report Number: 5623589
• Device Sequence Number: 1
• Product Code: FBK
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/08/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/02/2016
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: M00518350
• Device Lot Number: 18115984
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/08/2016
• Event Location: Hospital
• Date Report to Manufacturer: 04/08/2016
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 79 YR