MAUDE Adverse Event Report: CARDINAL HEALTH, INC. MONOJECT; NEEDLE, HYPODERMIC, SINGLE LUMEN

Model Number	8881200052
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that the shaft of the needle will come loose and shove back into the hub.Additional information received on 17apr2024 stated that sometimes the needle disengages from the hub and becomes two parts.The customer stated it seems like the needle is not crimped into the hub.This issue occurs after sticking cattle of all sizes and sometimes the needle stays in the cattle and they need to retrieve it.
Additional Manufacturer Narrative
Investigation summary: decontaminated samples were 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 samples, the reported issue was not confirmed.A corrective action is not applicable at this time.All information received will be used for further tracking and trending purposes.

• Brand Name: MONOJECT
• Common Device Name: NEEDLE, HYPODERMIC, SINGLE LUMEN
• 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: 19225926
• Report Number: 1017768-2024-00042
• Device Sequence Number: 8294604
• Product Code: FMI
• UDI-Device Identifier: 30884521007592
• UDI-Public: (01)30884521007592(17)200410(10)V14920
• Combination Product (Y/N): N
• Initial Reporter State: KS
• Initial Reporter Country: US
• PMA/510(K) Number: K854547
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/03/2024

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 Expiration Date: 04/10/2020
• Device Model Number: 8881200052
• Device Catalogue Number: 8881200052
• Device Lot Number: V14920
• 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: 04/16/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/01/2024
• Supplement Report FDA Received Date: 10/03/2024
• 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