MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC (SUBSIDIARY OF TELEFLEX INCORPORATED) ARROW ENDURANCE CATHETER; CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS

Lot Number 13F21M0122

Device Problems Break (1069); Entrapment of Device (1212)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 08/18/2022

Event Type  malfunction  

Event Description

This rn attempted to pull out edc.Upon slowly pulling out edc, the edc "snapped", and less than 1 inch of catheter came out of patients arm.The remaining catheter (approx.3 inches) remained in patients arm - edc was placed in patient's left lower anterior forearm.Md team notified and came to bedside.Pt denies any pain/discomfort.Md team obtained xray and vascular consult.Edc site circled with permanent marker.Fda safety report id# (b)(4).

• Brand Name: ARROW ENDURANCE CATHETER
• Type of Device: CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS
• Manufacturer (Section D): ARROW INTERNATIONAL LLC (SUBSIDIARY OF TELEFLEX INCORPORATED)
• MDR Report Key: 15276072
• MDR Text Key: 298570057
• Report Number: MW5111639
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• 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: 08/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/22/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Lot Number: 13F21M0122
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 38 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American