MAUDE Adverse Event Report: CARDINAL HEALTH MONOJECT SAFETY NDL 25 X 1; NEEDLE, HYPODERMIC, SINGLE LUMEN

Model Number	1182510
Medical Device Problem Codes	Crack (1135); Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/15/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that a pediatric patient (6 months of age) was to receive a pre-filled injection of pediarix i.M.When the nurse pushed on the syringe plunger, liquid shot out of the sides onto the nurse's gloved hand and on the paper covering on the exam table (as both were suddenly wet).The nurse is certain that although the child was stuck with the needle, none of the medication was received.On closer examination of the syringe, it was noticed that there was a crack in the luer lock piece of the needle hub which caused the vaccine to shoot out the sides.After examination, the staff disposed of the needle and the syringe, so there is nothing to return to the manufacturer.Staff inspected several other needles from that lot and did not identify any other defects.The infant had to return to be reinjected the next day which was upsetting to all involved but there was no actual harm due to this event.
Additional Manufacturer Narrative
An investigation is currently underway.Upon completion, the results will be forwarded.
Additional Manufacturer Narrative
Samples were not received for the investigation.The device history record was reviewed and indicated that the product was released accomplishing all quality standards.Because a sample was not returned, we were unable to perform a follow up investigation to include functional and visual evaluations to confirm the reported issue and determine a root cause.A corrective action is not applicable at this time.Functional testing and visual inspections are being performed according to our current quality standards and inspection procedures.If a sample is received at a later date, this complaint will be reopened for further investigation.This complaint will be used for tracking and trending purposes.

• Brand Name: MONOJECT SAFETY NDL 25 X 1
• 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: 15166315
• Report Number: 1282497-2022-10711
• Device Sequence Number: 19989304
• Product Code: FMI
• UDI-Device Identifier: 10884521544680
• UDI-Public: 10884521544680
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 12/07/2022

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
• Operator of Device: Health Professional
• Device Model Number: 1182510
• Device Catalogue Number: 1182510
• Device Lot Number: 02010014
• 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: 08/03/2022
• Supplement Date Received by Manufacturer: 08/03/2022
• Initial Report FDA Received Date: 08/04/2022
• Supplement Report FDA Received Date: 12/07/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Age: 6 MO
• Patient Sex: Unknown