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	06/22/2023
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 patient was receiving prbc's (packed red blood cells).The prbc's were completed and the rn (registered nurse) went to flush the line with ns (normal saline) and noticed the tip of the syringe was broken off and the iv tubing was malformed.
Additional Manufacturer Narrative
A photo sample was received for the investigation.The device history record was reviewed and indicated that the product was released accomplishing all quality standards.Upon review of the photo sample, the reported issue was confirmed; the luer tip was broken.A corrective action is not applicable at this time.If a physical sample is received at a later date, this complaint will be reopened for further investigation.

• 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: 17442639
• Report Number: 1915484-2023-01324
• Device Sequence Number: 2686484
• Product Code: FMF
• UDI-Device Identifier: 10192253034691
• UDI-Public: 10192253034691
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/06/2023

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: 6430822
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/14/2023
• Supplement Date Received by Manufacturer: 07/14/2023
• Initial Report FDA Received Date: 08/02/2023
• Supplement Report FDA Received Date: 10/06/2023
• 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