MAUDE Adverse Event Report: CARDINAL HEALTH MONOJCT 3ML SYR L-LOCK; SYRINGE, PISTON

Model Number	1180300777
Medical Device Problem Codes	Crack (1135); Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/18/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported when the nurse in ed was using this product, it leaked out dilaudid from a split on the side while air was being expelled from the syringe.
Additional Manufacturer Narrative
An investigation is currently underway.Upon completion, the results will be forwarded.
Additional Manufacturer Narrative
The device history record (dhr) review was performed.A visual inspection and functional testing were performed showing no issues.The equipment was reviewed for malfunctions or issues that could have contributed to the reported condition, but no such issues were observed during the review.There were no samples submitted for evaluation.The reported condition could not be confirmed.The complaint will be reopened if a sample is received.The exact root cause of the reported condition could not be determined without an actual sample to examine.Prior to a lot¿s release, the lot must be deemed acceptable by passing inspections that are based on a valid sampling plan.Inspectors routinely examine a statistical sample both physically and visually.Specifically, the samples will be inspected for cracks/ leaks.The lot met all defined acceptance requirements and was released.There was no evidence of any systemic failure of the manufacturing process.Based on the investigation and root cause analysis, the initiation of a corrective and preventative action (capa) is not required.This information will be utilized for trending purposes to determine the need for corrective actions.

• Brand Name: MONOJCT 3ML SYR L-LOCK
• Common Device Name: SYRINGE, PISTON
• 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: 15274802
• Report Number: 1017768-2022-01020
• Device Sequence Number: 2747532
• Product Code: FMF
• UDI-Device Identifier: 10884521012301
• UDI-Public: 10884521012301
• Combination Product (Y/N): N
• Initial Reporter State: RI
• 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
• Report Date (Section B): 10/14/2022

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: 1180300777
• Device Catalogue Number: 1180300777
• Device Lot Number: 127113
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/19/2022
• Supplement Date Received by Manufacturer: 08/19/2022
• Initial Report FDA Received Date: 08/23/2022
• Supplement Report FDA Received Date: 10/14/2022
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown