MAUDE Adverse Event Report: CARDINAL HEALTH MAGELLAN INSULIN 1ML 29GX1/2; NEEDLE, HYPODERMIC, SINGLE LUMEN

Model Number	8881892910
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/19/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported about 16-20 needles per box are breaking when the cap is removed.It appears the needle is already out of the syringe when it is uncapped, not that it's being pulled out by the cap.It is still attached to the syringe by a thin wire.There has been no patient or staff harm.
Additional Manufacturer Narrative
An investigation is currently underway.Upon completion, the results will be forwarded.
Additional Manufacturer Narrative
The device history record (dhr) review confirmed that the product was produced accomplishing quality requirements and released according to established procedures.The manufacturing site did not receive any samples for product analysis with this customer report.During manufacturing, the uv ovens cure the adhesive on the lock insert and the needle securing it to the syringe.When the rails leading into the uv oven do not have enough barrels to assemble, the process stops, an alarm is activated and the shutters close, blocking the light from the tip of the syringe to prevent over curing and damage to the syringes that were in the oven when the process stopped.A process change was implemented to update the program settings to adjust the uv oven shutter open and close timing and to remove the auto start for the uv ovens.A corrective and preventative action (capa) was initiated as a result of the investigation.This complaint will be used for tracking and trending purposes.

• Brand Name: MAGELLAN INSULIN 1ML 29GX1/2
• Common Device Name: NEEDLE, HYPODERMIC, SINGLE LUMEN
• 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: 13392484
• Report Number: 1915484-2022-01270
• Device Sequence Number: 4253257
• Product Code: FMI
• UDI-Device Identifier: 10884521005938
• UDI-Public: 10884521005938
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/17/2022

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: 8881892910
• Device Catalogue Number: 8881892910
• Device Lot Number: 129889
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/27/2022
• Supplement Date Received by Manufacturer: 01/27/2022
• Initial Report FDA Received Date: 01/31/2022
• Supplement Report FDA Received Date: 06/17/2022
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown