MAUDE Adverse Event Report: CARDINAL HEALTH MAGELL INSULIN 3/10ML 29GX1/2; SYRINGE, PISTON

Model Number 8881892930

Device Problem Fail-Safe Did Not Operate (4046)

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

Event Date 01/12/2022

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The customer reported that they were unable to get the safety lock to engage.The primary nurse brought it to the pcm for demo and after multiple attempts, was unable to get the lock to engage.The needle bent as well while attempting to place the orange cap back on the syringe.No injuries occurred.

Manufacturer Narrative

A device history record (dhr) review of the reported lot number confirmed that the product was produced accomplishing quality requirements and released according to established procedures.The manufacturing site received 3 samples for evaluation.Two of the syringe samples received were unpackaged and one of the syringe samples was packaged.A complete investigation was performed.Visual inspection to the quality inspection standard (qis) was conducted.Visual inspection of the unpackaged syringe samples identified bent cannula and the safety lock was locked, therefore the shield appears to have functioned as required.Shield/collar lock and shield/collar spin testing was performed on the one packaged syringe sample and the device passed the specifications.The cannula was not bent on this sample.The safety shield functioned as expected.Based on the examination of the samples and the description provided by the customer it is likely a failure of the user to follow the instructions for use (ifu).There are two opportunities for the user to not follow the ifu and could report a failure of the safety shield.First, the user is required to extend the safety shield forward until they feel a positive stop and hear an audible snap to secure the shield for safe transportation to the patient site.Had the user not extended to an audible snap, they may think the shield is not functioning properly.Second, after use of the syringe the user is to extend the shield fully forward until a click is heard and twist the shield until they feel a positive stop and hear an audible snap.Had the user not twisted the shield as instructed, the shield would appear to not function as intended.During the assembly of this product, inspectors routinely test samples for visual problem, shield retract force, shield extend force, shield-locking torque, shield/collar spin force, and detach force.The test results are reviewed for each shop order prior to release to verify that all testing during production was acceptable and within specification limits.The product cannot be accepted unless the acceptable quality level has been met.The following control mechanisms are in place to prevent the occurrence and acceptance of safety shield issues by the syringe assembly process.The molding process is validated, and the critical dimensions of the molded components are gauged to ensure molded components meet dimensional specifications.Preventive maintenance of the molding tool is conducted at required frequencies, in order to ensure process capability is maintained.Procedures and work instructions exist for the proper handling and verification of components and the operation of the syringe assembly machines.Personnel are trained and certified in the operation of the molding, assembly and packaging equipment, product evaluation and documentation requirements.The criteria are not met for a formal investigation, at this time.Complaint trends are evaluated during the monthly corrective and preventative action (capa) meeting to determine if a capa is warranted.At this time, a capa will not be initiated.This complaint will be used for tracking and trending purposes.

• Brand Name: MAGELL INSULIN 3/10ML 29GX1/2
• Type of Device: SYRINGE, PISTON
• Manufacturer (Section D): CARDINAL HEALTH; 1222 sherwood rd; norfolk NE 68701
• Manufacturer (Section G): CARDINAL HEALTH; 1222 sherwood rd; norfolk NE 68701
• Manufacturer Contact: jill saraiva ; 777 west street; mansfield, MA 02048 ; 5086183640
• MDR Report Key: 13537085
• MDR Text Key: 289749071
• Report Number: 1915484-2022-01273
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 30884521006632
• UDI-Public: 30884521006632
• 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: 03/23/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/15/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 8881892930
• Device Catalogue Number: 8881892930
• Device Lot Number: 032161X
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/24/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: A
• Patient Sequence Number: 1