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

Model Number	8881892910
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/27/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An investigation is currently underway.Upon completion, the results will be forwarded.
Event or Problem Description
The customer reported when the nurse pulls off the orange cap, the safety guide also pulls out, making the syringe unusable.
Additional Manufacturer Narrative
The device history record (dhr) was reviewed.Pieces were visually inspected and physically tested with no issues recorded relating to this customer report.The product and specification requirements were met with no non-conforming product identified relating to this customer report.The manufacturing site received one photograph for analysis.The photograph shows a 1ml magellan small safety syringe.A bent cannula and pulled lock insert can be observed in the photograph provided.The issue of pulled lock insert can be confirmed.The root cause was determined to be the potential of adhesive on the lock insert to not be fully cured.A corrective and preventative action (capa) was initiated.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; 777 west street; mansfield MA 02048
• 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: 15146302
• Report Number: 1915484-2022-01285
• Device Sequence Number: 5812318
• Product Code: FMI
• UDI-Device Identifier: 10884521005938
• UDI-Public: 10884521005938
• Combination Product (Y/N): N
• Initial Reporter State: MS
• 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): 08/29/2022

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: 203816X
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/28/2022
• Supplement Date Received by Manufacturer: 07/28/2022
• Initial Report FDA Received Date: 08/02/2022
• Supplement Report FDA Received Date: 08/29/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown