MAUDE Adverse Event Report: CARDINAL HEALTH MAGELLAN 3ML SFTY COMBO 25X5/8; SYRINGE, PISTON

Model Number 8881833558

Device Problem Fail-Safe Problem (2936)

Patient Problem Needle Stick/Puncture (2462)

Event Type  malfunction  

Event Description

The customer reported the employee engaged the safety device on the needle after giving a subcutaneous injection to a patient by pushing the needle end on the counter.The employee did not realize that the needle protruded through the end of the safety device resulting in a needlestick to her thumb when she disposed of it in the sharps container.

Manufacturer Narrative

An investigation is currently underway.Upon completion, the results will be forwarded.

Manufacturer Narrative

The device history record (dhr) review showed no issues were found.There were no samples or photos submitted for evaluation.The complaint will be reopened if a sample is received.The exact root cause could not be determined based on the available information.Prior to a lot¿s release, the lot must be deemed acceptable by passing inspections that are based on a valid sampling plan.Inspectors routinely examine a statistical sample both physically and visually.Specifically, the samples are inspected for safety shield issues.The lot met all defined acceptance requirements and was released.Based on the investigation and root cause analysis, the initiation of a corrective and preventative action (capa) is not required.This information will be utilized for trending purposes to determine the need for corrective actions.

• Brand Name: MAGELLAN 3ML SFTY COMBO 25X5/8
• Type of Device: SYRINGE, PISTON
• Manufacturer (Section D): CARDINAL HEALTH; 777 west street; mansfield MA 02048
• Manufacturer (Section G): CARDINAL HEALTH; 2010 east international speedw; deland FL 32724
• Manufacturer Contact: jill saraiva ; 777 west street; mansfield, MA 02048 ; 5086183640
• MDR Report Key: 16067807
• MDR Text Key: 306604307
• Report Number: 1017768-2022-01040
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/18/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/29/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 8881833558
• Device Catalogue Number: 8881833558
• Device Lot Number: 209481
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/15/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: A
• Patient Sequence Number: 1