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

Model Number 500758ST

Device Problem Break (1069)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Event Description

Broke in case.

• Brand Name: SLIDER NEEDLE 60° STRAIGHT
• Type of Device: SLIDER NEEDLE 60° STRAIGHT
• Manufacturer (Section D): T.A.G. MEDICAL PRODUCTS CORPORATION LTD; kibutz gaaton; gaaton, 25130 000; IS 25130000
• Manufacturer (Section G): T.A.G. MEDICAL PRODUCTS CORPORATION LTD; kibutz gaaton; gaaton, 25130 000; IS 25130000
• Manufacturer Contact: shlomi dines ; kibutz gaaton; gaaton, 25130-000 ; IS 25130000
• MDR Report Key: 7182035
• MDR Text Key: 97770745
• Report Number: 8043971-2017-00007
• Device Sequence Number: 1
• Product Code: HWQ
• UDI-Device Identifier: 10810190015589
• UDI-Public: 10810190015589
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/28/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/11/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: 500758ST
• Device Catalogue Number: 500758ST
• Device Lot Number: 16C05
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/07/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/01/2016
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1