MAUDE Adverse Event Report: NDC HOMECARE LLC MEDIFLO; PUMP, INFUSION, ELASTOMERIC

Model Number	MDC270050
Health Effect - Clinical Code	Chemical Exposure (2570)
Date of Event	01/17/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Middle-aged male with history of gastrohepatic lymphadenopathy.Procedure: chemo treatment per 5fu ball.Patient (pt) was receiving 5fu treatment per ball and was over 24 hours into treatment.Pt was sleeping and when awoke, noticed that the elastomeric ball was leaking.Patient placed a plastic bag around ball and came to infusion therapy.Infusion therapy reported that the ball was empty.It was not known the amount of medication was received.Patient¿s areas of exposure were cleaned and clothing discarded.Unknown harm to patient at this time.Manufacturer response for pump, infusion, elastomeric, mediflo (per site reporter).Reported by pharmacist.

• Brand Name: MEDIFLO
• Common Device Name: PUMP, INFUSION, ELASTOMERIC
• Manufacturer (Section D): NDC HOMECARE LLC; 402 bna drive; suite 500; nashville TN 37217
• MDR Report Key: 18621365
• Report Number: 18621365
• Device Sequence Number: 2368584
• Product Code: MEB
• UDI-Device Identifier: 00850007185022
• UDI-Public: (01)00850007185022(10)C23G067(17)260603(11)230703
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 01/23/2024
• Report Date (Section F): 01/23/2024

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 Model Number: MDC270050
• Device Catalogue Number: MDC270050
• Device Lot Number: C23G067
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Home
• Date Report to Manufacturer: 02/01/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/01/2024
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Male
• Patient Weight: 156 KG
• Date Report Sent to FDA: 01/23/2024