MAUDE Adverse Event Report: CONNECTOR++LUER (MALE) ENFIT; ENTERAL SPECIFIC TRANSITION CONNECTORS

Device Problem Connection Problem (2900)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Event Description

Spontaneous communication.Pt stated that both connects (female and male) don't work.He said he is tired of playing with it.I offered to transfer to pharmacist but pt refused.He said he is done with it and hung up.Unknown if patient missed dose or experienced an adverse event.Unknown if device on hand.Unknown lot and expiration.Reported to (b)(6)/caremark by pt/caregiver.

• Brand Name: CONNECTOR++LUER (MALE) ENFIT
• Type of Device: ENTERAL SPECIFIC TRANSITION CONNECTORS
• MDR Report Key: 14398187
• MDR Text Key: 291815544
• Report Number: MW5109689
• Device Sequence Number: 1
• Product Code: PIO
• Combination Product (y/n): Y
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/30/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/12/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Is the Reporter a Health Professional?: Yes
• Patient Sequence Number: 1
• Patient Sex: Male