MAUDE Adverse Event Report: CARDINAL HEALTH MONOJCT 35ML SYR L-LOCK; SYRINGE, PISTON

Model Number	1183500777
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/21/2023
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 that the outer wall of the luer lock area of the syringe is breaking when pushing saline.
Additional Manufacturer Narrative
A physical sample was received at the plant for the investigation.Photo and video samples were also received for analysis.The device history record was reviewed and indicated that the product was released accomplishing all quality standards.Upon visual and functional evaluation of the physical sample, the defect was not confirmed.Upon visual evaluation of the photo and video sample, the defect was confirmed; the luer skirt was broken.Based on the investigation, the root cause could not be determined at this time.A corrective action is not applicable at this time.This complaint will be used for tracking and trending purposes.

• Brand Name: MONOJCT 35ML SYR L-LOCK
• Common Device Name: SYRINGE, PISTON
• 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: 17310460
• Report Number: 1915484-2023-01319
• Device Sequence Number: 7157853
• Product Code: FMF
• UDI-Device Identifier: 10192253034691
• UDI-Public: 10192253034691
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 10/31/2023

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
• Device Model Number: 1183500777
• Device Catalogue Number: 1183500777
• Device Lot Number: 225563X
• 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: 06/21/2023
• Supplement Date Received by Manufacturer: 06/21/2023
• Initial Report FDA Received Date: 07/12/2023
• Supplement Report FDA Received Date: 10/31/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown