MAUDE Adverse Event Report: CARDINAL HELATH MONOJCT 6ML SYR L-SLIP; SYRINGE, PISTON

Model Number	1180600555
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Exposure to Body Fluids (1745)
Date of Event	10/03/2022
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 that while using the syringe in a transfer device, the tip (which does not have a luer tip, it has a smooth tip ending) broke off.This occurred in the ed.No injuries were reported.Per additional information provided on (b)(6) 2022, they were taking the syringe and connecting it to a vacutainer and the tip of the syringe broke which caused blood to splash on the patient, nurse, and room.No adverse events occurred.
Additional Manufacturer Narrative
The device history record was reviewed and indicated that the product was released accomplishing all quality standards.This product was manufactured and packaged on dec.21-23, 2021.During the manufacturing process a sample of syringes were visually and functionally inspected with zero issues recorded relating to this report.A sample was not received for the investigation.Because a sample was not returned, we were unable to perform functional and visual evaluations to confirm the reported condition and determine the root cause.If a sample is received at a later date, the complaint will be reopened, and the investigation will be updated accordingly.A corrective action is not applicable at this time.Functional testing and visual inspections are performed according to our current quality standards and inspection procedures.This complaint will be used for tracking and trending purposes.

• Brand Name: MONOJCT 6ML SYR L-SLIP
• Common Device Name: SYRINGE, PISTON
• Manufacturer (Section D): CARDINAL HELATH; 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: 15587978
• Report Number: 1915484-2022-01297
• Device Sequence Number: 2810245
• Product Code: FMF
• UDI-Device Identifier: 10884521013568
• UDI-Public: 10884521013568
• Combination Product (Y/N): N
• Initial Reporter State: OK
• 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): 11/02/2022

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
• Device Model Number: 1180600555
• Device Catalogue Number: 1180600555
• Device Lot Number: 202600X
• 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: 10/04/2022
• Supplement Date Received by Manufacturer: 10/04/2022
• Initial Report FDA Received Date: 10/12/2022
• Supplement Report FDA Received Date: 11/02/2022
• 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