MAUDE Adverse Event Report: GALT MEDICAL CORP. TEARAWAY INTRODUCER SET; INTRODUCER, CATHETER

Model Number	INT-106-04
Health Effect - Clinical Code	Needle Stick/Puncture (2462)
Date of Event	11/18/2023
Type of Reportable Event	Malfunction
Event or Problem Description
While placing 5 f picc the catheter was unable to thread through the 5 french galt tearaway introducer.Ultimately, patient required a second needle insertion after this introducer was removed.

• Brand Name: TEARAWAY INTRODUCER SET
• Common Device Name: INTRODUCER, CATHETER
• Manufacturer (Section D): GALT MEDICAL CORP.; 2200 merritt drive; garland TX 75041
• MDR Report Key: 18845733
• Report Number: 18845733
• Device Sequence Number: 12720820
• Product Code: DYB
• UDI-Device Identifier: 00841268102118
• UDI-Public: (01)00841268102118
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 12/14/2023
• Report Date (Section F): 12/14/2023

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: INT-106-04
• Device Catalogue Number: INT-106-04
• Device Lot Number: 23033940
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 03/06/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/06/2024
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Age: 70 YR
• Patient Sex: Female
• Patient Weight: 50 KG
• Date Report Sent to FDA: 12/14/2023