MAUDE Adverse Event Report: CARDINAL HEALTH MONOJCT 20ML SYR L-LOCK; SYRINGE, PISTON

Model Number	1182000777
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported the inability to remove tamper evident caps and subsequently breaking the tip in the process of trying to get it off.
Additional Manufacturer Narrative
An investigation is currently underway.Upon completion, the results will be forwarded.
Additional Manufacturer Narrative
Based on the information available to us, we were able to confirm the event, and determined that the syringe tips were broken.Six unpackaged 20ml luer lock syringes were received for evaluation, five red tip caps and one clear plastic cover were included.Visual inspections to the quality inspection standard were conducted.A broken luer tip was identified on all six of the syringe samples.A cracked syringe barrel face was observed on five of the syringe samples and cracked/damaged luer skirt was identified on three of the syringe samples.The luer tip and luer skirt were completely broken off of one of the syringe samples.A sticky substance was adhered to the outside of each of the syringe barrels, most likely from a label.A visual inspection of the five red tip caps found the broken luer tip inside each of the tip caps.The device history record was reviewed and indicated that the product was released accomplishing all quality standards.Based on the available information, an exact root cause could not be determined.No corrective and preventive actions will be initiated at this time.All information received will be used for further tracking and trending purposes.

• Brand Name: MONOJCT 20ML 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: 17043565
• Report Number: 1915484-2023-01315
• Device Sequence Number: 12023073
• Product Code: FMF
• UDI-Device Identifier: 10884521010802
• UDI-Public: 10884521010802
• 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): 06/28/2023

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: 1182000777
• Device Catalogue Number: 1182000777
• Device Lot Number: 229763X
• 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: 05/24/2023
• Supplement Date Received by Manufacturer: 05/24/2023
• Initial Report FDA Received Date: 06/01/2023
• Supplement Report FDA Received Date: 06/28/2023
• 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