MAUDE Adverse Event Report: TELEFLEX MEDICAL LANGSTON; CATHETER, INTRAVASCULAR, DIAGNOSTIC

Model Number	IPN913559
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/08/2020
Type of Reportable Event	Malfunction
Event or Problem Description
Incident description: the langston catheter draws back air while in the patient.Upon examination, there is a hole near the hub.The procedure was carried out with no complications to the patient.

• Brand Name: LANGSTON
• Common Device Name: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): TELEFLEX MEDICAL; 3015 carrington mill blvd.; morrisville NC 27560
• MDR Report Key: 10470991
• Report Number: 10470991
• Device Sequence Number: 2345073
• Product Code: DQO
• UDI-Device Identifier: 10841156100513
• UDI-Public: (01)10841156100513(17)211120(10)662903
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 08/24/2020
• Report Date (Section F): 08/24/2020

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: IPN913559
• Device Catalogue Number: 5540
• Device Lot Number: 662903
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 08/31/2020
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/31/2020
• Patient Sequence Number: 1
• Patient Weight: 66
• Date Report Sent to FDA: 08/24/2020