MAUDE Adverse Event Report: CARDINAL HEALTH MONOJECT SAFETY NEEDLE 23 X 1 1/2; NEEDLE, HYPODERMIC, SINGLE LUMEN

Model Number	1182315
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The complainant indicated that the device will not be returned for evaluation; therefore, a failure analysis is not available, and we are not able to determine the relationship between this device and the cause for this event.  as part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product.  if additional information or the sample is received, the investigation will be reopened and responded to accordingly.
Event or Problem Description
The customer reported that the staff members stated that when the safety device is activated, it does not seal the end of the needle so blood is leaking out of the needle before they can remove the needle from the syringe.The staffs also reported that they are having more problems accessing the veins with these needles unless the vein is huge, resulting in multiple sticks to the patient.Additional information was received and stated that the needle didn't not seem to pierce the skin as easily as other products.Per staff members, the needles are flimsy and bend easily, making it more difficult to access the vein.The customer itself experienced this issue when she performed a hand stick last week.The customer further stated that activation of the shield is not a problem, the problem is after it is activated, the needles leak.The activation performs as expected.
Additional Manufacturer Narrative
Section b5 has been updated to include additional information.
Event or Problem Description
The customer reported that the staff members stated that when the safety device is activated, it does not seal the end of the needle so blood is leaking out of the needle before they can remove the needle from the syringe.The staffs also reported that they are having more problems accessing the veins with these needles unless the vein is huge, resulting in multiple sticks to the patient.Additional information was received and stated that the needle didn¿t not seem to pierce the skin as easily as other products.Per staff members, the needles are flimsy and bend easily, making it more difficult to access the vein.The customer itself experienced this issue when she performed a hand stick last week.The customer further stated that activation of the shield is not a problem, the problem is after it is activated, the needles leak.The activation performs as expected.The customer further stated that the needles flex more readily which makes venous access more difficult unless patient has particularly accessible veins.The customer has noticed dimpling of patients¿ skin.Per customer, after withdrawal of monoject needle and activation of safety feature, blood leaks from the bevel of the needle.The leaks are more readily measured in drops rather than ml.The needle stiffness is inconsistent with customer expectation, different than that of similar size and gauge.
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 samples were received for the analysis.All samples passed the visual check on the needle tip.Penetration test, stiffness test was performed.The test results showed that all the samples were within the product specific requirement.Simulation test was conducted, and the syringe was filled with the blood simulant, activation was performed with no anomalies found.It is possible that a drop of blood simulant is visible immediately after activation, but it remains in the safety arm in proximity of the needle tip with no risks for the user and patient.It is important that the end user does not touch or apply force on the plunger during activation to avoid the ejection of blood from the needle tip.Based on the investigation, the reported issues could not be confirmed.The root cause could not be identified.At this time, a corrective and preventive action is not deemed necessary.This complaint will be used for qa tracking and trending purposes.

• Brand Name: MONOJECT SAFETY NEEDLE 23 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; 777 west street; mansfield MA 02048
• Manufacturer Contact: jill saraiva ; 777 west street; mansfield, MA 02048 ; 5086183640
• MDR Report Key: 13236837
• Report Number: 1282497-2022-10672
• Device Sequence Number: 14591324
• Product Code: FMI
• UDI-Device Identifier: 10884521544666
• UDI-Public: 10884521544666
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/16/2022

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: 1182315
• Device Catalogue Number: 1182315
• Device Lot Number: 02009038
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/05/2022
• Supplement Date Received by Manufacturer: 01/05/2022; 01/05/2022
• Initial Report FDA Received Date: 01/12/2022
• Supplement Report FDA Received Date: 01/12/2022; 03/17/2022
• 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