MAUDE Adverse Event Report: T.A.G. MEDICAL PRODUCTS CORPORATION LTD SLIDER NEEDLE 60° STRAIGHT

Model Number	500758ST
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Event or Problem Description
Broke in case.

• Brand Name: SLIDER NEEDLE 60° STRAIGHT
• Common Device Name: SLIDER NEEDLE 60° STRAIGHT
• Manufacturer (Section D): T.A.G. MEDICAL PRODUCTS CORPORATION LTD; kibutz gaaton; gaaton, 25130 000; IS 25130000
• MDR Report Key: 7182035
• Report Number: 8043971-2017-00007
• Device Sequence Number: 16505777
• Product Code: HWQ
• UDI-Device Identifier: 10810190015589
• UDI-Public: 10810190015589
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 12/28/2017

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: Physician
• Device Model Number: 500758ST
• Device Catalogue Number: 500758ST
• Device Lot Number: 16C05
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/07/2017
• Initial Report FDA Received Date: 01/11/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1