MAUDE Adverse Event Report: CARDINAL HEALTH, INC. MONOJECT; CANNULA, SURGICAL, GENERAL & PLASTIC SURGERY

Model Number	8881540111
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/01/2024
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 tip is not threading down into the syringe all the way causing it to leak medication.
Additional Manufacturer Narrative
Product samples were returned for evaluation.Upon a preliminary review of the returned product, it was noticed that the product number was reported incorrectly on the initial report.This follow-up report is to correct the inaccurate data that was initially reported, as well as provide additional product information.
Additional Manufacturer Narrative
The device history record was reviewed and indicated that the product was released accomplishing all quality standards.The lot was manufactured between 19apr2024 and 22apr2024.Sample were returned for evaluation.Functional testing was performed per procedure.The reported condition was unable to be confirmed or duplicated.Based on the available information, a root cause could not be identified.A corrective and preventive action (capa) is not applicable at this time.All information received will be used for further tracking and trending purposes.

• Brand Name: MONOJECT
• Common Device Name: CANNULA, SURGICAL, GENERAL & PLASTIC SURGERY
• 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 ; 3651 birchwood drive; waukegan, IL 60085 ; 5086183640
• MDR Report Key: 19669807
• Report Number: 1423537-2024-00061
• Device Sequence Number: 3136866
• Product Code: GEA
• UDI-Device Identifier: 30884521102754
• UDI-Public: (01)30884521102754(17)290228(10)24D297
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/25/2024

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: 8881540111
• Device Catalogue Number: 8881540111
• Device Lot Number: 24D297
• 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: 07/01/2024
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 07/03/2024
• Supplement Report FDA Received Date: 08/08/2024; 09/25/2024
• 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