MAUDE Adverse Event Report: ARROW INTERNATIONAL, INC. (SUBSIDIARY OF TELEFLEX, INCORPORATED) ENDURANCE EXTENDED DWELL PERIPHERAL IV 18G X 8CM; CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS

Lot Number 14F21H0187

Device Problem Break (1069)

Patient Problem Foreign Body In Patient (2687)

Event Date 11/25/2021

Event Type  malfunction  

Event Description

Catheter broke during piv insertion.Patient experienced retained catheter fragment in soft tissue.Consult to ir and vascular, no surgical intervention required.Fda safety report id# (b)(4).

• Brand Name: ENDURANCE EXTENDED DWELL PERIPHERAL IV 18G X 8CM
• Type of Device: CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS
• Manufacturer (Section D): ARROW INTERNATIONAL, INC. (SUBSIDIARY OF TELEFLEX, INCORPORATED)
• MDR Report Key: 12953934
• MDR Text Key: 281938564
• Report Number: MW5105871
• 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: 12/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/06/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Lot Number: 14F21H0187
• Is the Reporter a Health Professional?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 78 YR
• Patient Sex: Male