MAUDE Adverse Event Report: T.A.G. MEDICAL PRODUCTS CORPORATION LTD SLIDER NEEDLE 45 DEG LEFT

Model Number	3910-500-752
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	02/13/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The sides of the section as seen in the picture of the device are even and meet the engineering requirements.The device was wrong use (see remark marked above with an arrow) causing the device failure.
Event or Problem Description
Slider needle snapped at distal tip in patient.

• Brand Name: SLIDER NEEDLE 45 DEG LEFT
• Common Device Name: SLIDER NEEDLE 45 DEG LEFT
• Manufacturer (Section D): T.A.G. MEDICAL PRODUCTS CORPORATION LTD; kibutz gaaton; gaaton, 25130 000; IS 25130000
• MDR Report Key: 10777402
• Report Number: 8043971-2020-01420
• Device Sequence Number: 2908627
• Product Code: MBI
• UDI-Device Identifier: 10810190015527
• UDI-Public: 10810190015527
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 02/13/2020

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
• Operator of Device: Health Professional
• Device Model Number: 3910-500-752
• Device Catalogue Number: 3910-500-752
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/13/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/13/2020
• Initial Report FDA Received Date: 11/03/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1