MAUDE Adverse Event Report: CARDINAL HEALTH SAFETY NEEDLE 22 X 1 1/2; NEEDLE, HYPODERMIC, SINGLE LUMEN

Model Number	8881850215
Medical Device Problem Code	Fail-Safe Problem (2936)
Health Effect - Clinical Code	Needle Stick/Puncture (2462)
Date of Event	09/19/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported through medwatch that a registered nurse (rn) was to administer an intramuscular injection of methergine.The rn used the safety feature to cap the needle and it did not click.The rn was poked on the left pointer finger by the needle when the guide did not close fully.The patient was aware of the rn's exposure and consented to laboratory blood work.
Additional Manufacturer Narrative
An investigation is currently underway.Upon completion, the results will be forwarded.
Additional Manufacturer Narrative
The device history record (dhr) could not be reviewed because a lot number was not available.All dhrs are reviewed and approved by quality prior to release of product.There were no samples received for examination.The reported condition could not be confirmed.The complaint will be reopened if a sample is received.There is insufficient information to determine a most probable root cause.Corrective or preventive actions will not be taken at this time.This complaint will be used for tracking and trending purposes.

• Brand Name: SAFETY NEEDLE 22 X 1 1/2
• Common Device Name: NEEDLE, HYPODERMIC, SINGLE LUMEN
• Manufacturer (Section D): CARDINAL HEALTH; 777 west street; mansfield MA 02048
• 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: 18355538
• Report Number: 1017768-2023-01112
• Device Sequence Number: 6924387
• Product Code: FMI
• UDI-Device Identifier: 10884521000087
• UDI-Public: 10884521000087
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/28/2024

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: 8881850215
• Device Catalogue Number: 8881850215
• 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: 12/05/2023
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/19/2023
• Supplement Report FDA Received Date: 05/28/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown