MAUDE Adverse Event Report: CARDINAL HEALTH MAGELLAN; NEEDLE, HYPODERMIC, SINGLE LUMEN

Model Number	8881833558
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	02/02/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The issue is that the needle is not always ¿preattached¿ well and becomes detached when trying to draw out the medication for use during our iontophoresis treatment, thus forcing the clinician to either dump it into the sharps container and get another one or try to push the needle back into the syringe (by holding onto the non-sharp part of the needle where it inserts into the syringe.This is an unsafe practice.Two lot numbers are affected, 118056 and s14684.Not all devices in these lots exhibited failures.The failures were sporadic.

• Brand Name: MAGELLAN
• Common Device Name: NEEDLE, HYPODERMIC, SINGLE LUMEN
• Manufacturer (Section D): CARDINAL HEALTH; 3651 birchwood drive; waukegan IL 60085
• MDR Report Key: 19095775
• Report Number: 19095775
• Device Sequence Number: 7682246
• Product Code: FMF
• UDI-Device Identifier: 10884521005846
• UDI-Public: (01)10884521005846
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/13/2024
• Report Date (Section F): 02/13/2024

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
• Operator of Device: Health Professional
• Device Model Number: 8881833558
• Device Catalogue Number: 8881833558
• Device Lot Number: 118056, S14684
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Ambulatory Surgical Facility
• Date Report to Manufacturer: 04/12/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/12/2024
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown
• Date Report Sent to FDA: 02/13/2024