MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC (SUBSIDIARY OF TELEFLEX INCORPORATED) PEDIATRIC TWO LUMEN 4FR 13CM CEN; CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS

Device Problem Material Deformation (2976)

Patient Problem Insufficient Information (4580)

Event Date 07/14/2021

Event Type  No Answer Provided  

Event Description

Dr.Reported that during the insertion of the central line in the critical pediatric patient there was difficulty threading the guide wire causing it to kink and required opening a second kit to obtain another wire to complete the procedure.Fda safety report id# (b)(4).

• Brand Name: PEDIATRIC TWO LUMEN 4FR 13CM CEN
• Type of Device: CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS
• Manufacturer (Section D): ARROW INTERNATIONAL LLC (SUBSIDIARY OF TELEFLEX INCORPORATED); morrisville NC 27560
• MDR Report Key: 12202344
• MDR Text Key: 262944841
• Report Number: MW5102633
• Device Sequence Number: 1
• Product Code: FOZ
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 07/16/2021

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?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/20/2021
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 17 MO
• Patient Weight: 10