MAUDE Adverse Event Report: CARDINAL HEALTH MONOJECT SAFETY NDL 22 X 1.5; NEEDLE, HYPODERMIC, SINGLE LUMEN

Model Number	1182215
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/02/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that the needle is weakening as there is a hole near the safety.Per additional information received on (b)(6) 2022, the staff explained that the needle was under pressure when it started ¿squirting narcotic out the side of the needle hub¿ they were looking for the hole and took the safety device off in order to find the hole.
Additional Manufacturer Narrative
An investigation is currently underway.Upon completion, the results will be forwarded.
Additional Manufacturer Narrative
The lot number was provided, and the device history record (dhr) was reviewed indicating that the product was released accomplishing all quality standards.As part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product.The sample was received for the evaluation and the reported issue is confirmed.The potential root cause of the reported issue could be caused during the product transfer in the production process.However, the definite root cause could not be determined.As an action plan, the manufacturing partner has informed all related workers about the reported issue and requested them to pay attention to this kind of issue.This is considered as an isolated event within this lot.At this time, a corrective and preventive action is not deemed necessary.We will keep monitoring the process for any adverse trends that require immediate attention.This complaint will be used for qa tracking and trending purposes.

• Brand Name: MONOJECT SAFETY NDL 22 X 1.5
• Common Device Name: NEEDLE, HYPODERMIC, SINGLE LUMEN
• Manufacturer (Section D): CARDINAL HEALTH; 777 west street; mansfield MA 02048
• Manufacturer (Section G): CARDINAL HEALTH; 777 west street; mansfield MA 02048
• Manufacturer Contact: jill saraiva ; 777 west street; mansfield, MA 02048 ; 5086183640
• MDR Report Key: 14859224
• Report Number: 1282497-2022-10701
• Device Sequence Number: 4909425
• Product Code: FMI
• UDI-Device Identifier: 10884521544659
• UDI-Public: 10884521544659
• Combination Product (Y/N): N
• 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): 11/14/2022

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: 1182215
• Device Catalogue Number: 1182215
• Device Lot Number: 02012067
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/20/2022
• Supplement Date Received by Manufacturer: 06/20/2022
• Initial Report FDA Received Date: 06/29/2022
• Supplement Report FDA Received Date: 11/14/2022
• 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