MAUDE Adverse Event Report: TELEFLEX INCORPORATED ARROW PRESSURE INJECTABLE ARROWG+ARD BLUE PLUS FOUR-LUMEN CVC; CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS

Model Number IPN922683

Device Problem Break (1069)

Patient Problem Insufficient Information (4580)

Event Date 04/20/2022

Event Type  malfunction  

Event Description

Gray port snapped off from lumen.

• Brand Name: ARROW PRESSURE INJECTABLE ARROWG+ARD BLUE PLUS FOUR-LUMEN CVC
• Type of Device: CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS
• Manufacturer (Section D): TELEFLEX INCORPORATED; po box 12600; durham NC 27709
• MDR Report Key: 14309035
• MDR Text Key: 290957739
• Report Number: 14309035
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 04/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/06/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: IPN922683
• Device Catalogue Number: ASK-45854-BJC1
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/27/2022
• Event Location: Hospital
• Date Report to Manufacturer: 05/06/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1