MAUDE Adverse Event Report: CARDINAL HEALTH 200, LLC MONOJECT; SYRINGE, PISTON

Model Number	8881512977
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/22/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that the tip broke off inside the needle extender.
Additional Manufacturer Narrative
An investigation is currently underway.Upon completion, the results will be forwarded.
Additional Manufacturer Narrative
Samples were not received for the investigation.The device history record was reviewed and indicated that the product was released accomplishing all quality standards.Based on the information available to us, we were unable to confirm the event.In the meantime, all information received will be used for further tracking and trending purposes.If more information is received at a later date, the investigation will be reopened, and the investigation will be updated accordingly.
Event or Problem Description
The customer reported that the tip broke off inside the needle extender.On (b)(6) 2024 the customer stated it is unknown which needle extender was used with the syringe.The issue occurred before a suction dilation & curettage procedure.
Additional Manufacturer Narrative
The following sections were updated: section b3 date of event; section b5 describe event or problem; section d1 brand name; section d3 manufacturer name; section d4 unique identifier (udi) #.The following sections were added: section d4 expiration date #; section g4 pma/510(k)number;  section h5 labeled for single use?.
Additional Manufacturer Narrative
One device was received for evaluation and the reported issue was observed.The device history record was reviewed and indicated that the product was released accomplishing all quality standards.Based on all available information, no abnormal conditions were found that could trigger this issue.Manufacturing personnel were notified of this complaint for awareness.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 200, LLC; 3651 birchwood drive; waukegan IL 60085
• Manufacturer (Section G): CARDINAL HEALTH; calle 9 sur no. 125 cuidad ind; tijuana 22500 ; MX 22500
• Manufacturer Contact: jill saraiva ; 3651 birchwood drive; waukegan, IL 60085 ; 5086183640
• MDR Report Key: 19689941
• Report Number: 1423537-2024-00062
• Device Sequence Number: 12547095
• Product Code: FMF
• UDI-Device Identifier: 10192253030686
• UDI-Public: (01)10192253030686(17)271231(10)2302418264
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K945715
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 10/30/2024

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: 8881512977
• Device Catalogue Number: 8881512977
• Device Lot Number: 2302418264
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/05/2024
• Supplement Date Received by Manufacturer: Not provided; Not provided; Not provided
• Initial Report FDA Received Date: 07/08/2024
• Supplement Report FDA Received Date: 07/25/2024; 08/15/2024; 10/30/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/30/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown