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

Model Number	8881540133
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/21/2024
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 multiple vial access syringes were cracking upon use.One sample was retained.Per additional information received, the tip was cracking.There was no medical intervention required.
Additional Manufacturer Narrative
A sample was received at the plant for the investigation.The device history record was reviewed and indicated that the product was released accomplishing all quality standards.Upon a visual evaluation of the sample, the defect was confirmed for the reported event.Based on the investigation, the root cause could not be determined at this time.A corrective action is not applicable at this time.This complaint will be used for tracking and trending purposes.The following sections were corrected or completed: section d1 brand name: monoject; section d3 manufacturer name city and state: cardinal health 200, inc.Section d4 unique identifier (udi) #: (b)(4).

• 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 ; 777 west street; mansfield, MA 02048 ; 5086183640
• MDR Report Key: 19003002
• Report Number: 1017768-2024-00037
• Device Sequence Number: 8464686
• Product Code: GEA
• UDI-Device Identifier: 10884521082946
• UDI-Public: (01)10884521082946(17)280831(10)23L125
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer,Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 09/11/2024

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: 8881540133
• Device Catalogue Number: 8881540133
• Device Lot Number: 23L125
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/22/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/29/2024
• Supplement Report FDA Received Date: 09/11/2024
• 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