MAUDE Adverse Event Report: CARDINAL HEALTH, INC. MONOJECT; SYRINGE, PISTON

Model Number	8881513231
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/18/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that they have one box of lot number 22l082 that had 15 defective syringes in it.The needle is a different color on some and the connection between syringe and needle is cracked or completely gone on some of them.Photos were provided which appear to show broken/cracked/missing luer tips.
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 as two photos were provided for evaluation and damage to the product can be seen however no physical samples were returned for analysis.A review of the device history record indicated that the product was released accomplishing all quality standards.The lot was produced between 29oct2022 and 01nov2022.The exact root cause could not be determined without a physical sample to examine.A corrective and preventive action is not applicable at this time all information received will be used for further tracking and trending purposes.

• Brand Name: MONOJECT
• Common Device Name: SYRINGE, PISTON
• Manufacturer (Section D): CARDINAL HEALTH, INC.; 3651 birchwood drive; waukegan IL 60085
• Manufacturer (Section G): CARDINAL HEALTH; 2010 east international speedw; deland FL 32724
• Manufacturer Contact: jill saraiva ; 777 west street; mansfield, MA 02048 ; 5086183650
• MDR Report Key: 17919748
• Report Number: 1017768-2023-01095
• Device Sequence Number: 11465763
• Product Code: FMF
• UDI-Device Identifier: 20884521012711
• UDI-Public: (01)20884521012711(10)22L082
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K852544
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/03/2024

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: 8881513231
• Device Catalogue Number: 8881513231
• Device Lot Number: 22L082
• 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: 10/05/2023
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/12/2023
• Supplement Report FDA Received Date: 10/03/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown