MAUDE Adverse Event Report: TELEFLEX MEDICAL ARROW; CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS

Model Number ARWEDC00620

Device Problems Crack (1135); Fluid/Blood Leak (1250)

Patient Problem Failure of Implant (1924)

Event Date 01/16/2023

Event Type  malfunction  

Event Description

Requested to restart iv on patient in 3 west.Patient had an extended dwell catheter which was not functioning well and another iv which was leaking.I tried to troubleshoot the extended dwell by changing the dressing but when i flushed it, i noted that the catheter was cracked at the hub, the very end of the catheter, most distal to patient.All of the flush leaked out of that crack, and it was obviously unable to be used.I removed the catheter which was otherwise intact.I notified the patient's rn and she kept the catheter to show her unit resource/education rn.Addendum: device sequestered.Manufacturer response for 20g extended dwell peripheral catheter, arrow endurance catheter 20g (per site reporter).[redacted date] - email request for an rma/mailer sent to rep.[redacted date] - rep.Will pick up the sample from [redacted name] on [redacted date].[redacted date] - [redacted name] retrieved the sample from [redacted name] (b)(6).[redacted date] - teleflex final report received.

• Brand Name: ARROW
• Type of Device: CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS
• Manufacturer (Section D): TELEFLEX MEDICAL; 3015 carrington mill blvd; morrisville NC 27560
• MDR Report Key: 17190372
• MDR Text Key: 317748641
• Report Number: 17190372
• 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: Nurse
• Type of Report: Initial
• Report Date: 06/13/2023

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
• Device Operator: Health Professional
• Device Model Number: ARWEDC00620
• Device Catalogue Number: EDC-00820
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/08/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/13/2023
• Event Location: Hospital
• Date Report to Manufacturer: 06/23/2023
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/23/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1