MAUDE Adverse Event Report: CARDINAL HEALTH MONOJECT SAFETY NDL 25 X 5/8; NEEDLE, HYPODERMIC, SINGLE LUMEN

Model Number	1182558
Medical Device Problem Codes	Crack (1135); Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/28/2022
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 the side of the orange needle had a slight split in the plastic resulting in treatment being leaked onto the nurse administering it.No harm or injury was reported.
Additional Manufacturer Narrative
The device history record review of the reported lot number shows evidence that the product was released according to all established procedures and qa documentation.No anomalies found on batch documentation.No samples or photos were received by the customer for evaluation.Fifty pieces of retained samples were visually checked with no anomalies found on the needle hub.Five pieces of retained samples were physically tested for stress cracking per iso guidelines and all samples passed the test.With no samples/photos of the reported issue and with no information about the handling of the device during assembling the needle with the syringe, it is not possible to identify the root cause of the issue.As a result, a corrective action is not required at this time.This complaint will be used for tracking and trending purposes and to monitor the product for reoccurrence.

• Brand Name: MONOJECT SAFETY NDL 25 X 5/8
• Common Device Name: NEEDLE, HYPODERMIC, SINGLE LUMEN
• Manufacturer (Section D): CARDINAL HEALTH; 777 west st; mansfield MA 02048
• Manufacturer (Section G): CARDINAL HEALTH; 777 west st; mansfield MA 02048
• Manufacturer Contact: jill saraiva ; 777 west st; mansfield, MA 02048 ; 5086183640
• MDR Report Key: 14112883
• Report Number: 1282497-2022-10686
• Device Sequence Number: 2135137
• Product Code: FMI
• UDI-Device Identifier: 10884521544710
• UDI-Public: 10884521544710
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/24/2022

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: 1182558
• Device Catalogue Number: 1182558
• Device Lot Number: 02102036
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/12/2022
• Supplement Date Received by Manufacturer: 04/12/2022
• Initial Report FDA Received Date: 04/14/2022
• Supplement Report FDA Received Date: 06/24/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown