MAUDE Adverse Event Report: TELEFLEX MEDICAL ARROW AUTOFUSER ; PUMP INFUSION ELASTOMERIC

Lot Number 74B1902043

Device Problem Leak/Splash (1354)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/28/2019

Event Type  malfunction  

Event Description

Significant leaking from a filled arrow autofuser pump.No deviation from filling of the pump.I have a picture of the product.(b)(4).

• Brand Name: ARROW AUTOFUSER
• Type of Device: PUMP INFUSION ELASTOMERIC
• Manufacturer (Section D): TELEFLEX MEDICAL
• MDR Report Key: 8577906
• MDR Text Key: 144135659
• Report Number: MW5086363
• Device Sequence Number: 1
• Product Code: MEB
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date: 04/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/01/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/10/2019
• Device Lot Number: 74B1902043
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1