MAUDE Adverse Event Report: AVANOS MEDICAL, INC. ON-Q CB004 400ML SELECT-A-FLOW PUMP; PUMP, INFUSION, ELASTOMERIC

Model Number CB004

Device Problems Component Missing (2306); Detachment of Device or Device Component (2907)

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

Event Date 10/15/2020

Event Type  malfunction  

Event Description

We receive prefilled on-q pumps from (b)(6) compounding pharmacy.(b)(6) purchases the empty pumps from avanos and then fills them for us with bupivacaine 0.125%.We received one pump that was completely missing the dial that adjusts the flow of the pump.We have also had numerous patients call after discharge stating that the dial has fallen off.Fda safety report id# (b)(4).

• Brand Name: ON-Q CB004 400ML SELECT-A-FLOW PUMP
• Type of Device: PUMP, INFUSION, ELASTOMERIC
• Manufacturer (Section D): AVANOS MEDICAL, INC. ; alpharetta GA 30004
• MDR Report Key: 10717964
• MDR Text Key: 212853540
• Report Number: MW5097383
• Device Sequence Number: 1
• Product Code: MEB
• Combination Product (y/n): Y
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date: 10/20/2020

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: No Information
• Device Model Number: CB004
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/21/2020
• Patient Sequence Number: 1