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

Model Number	8881103066
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/21/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An investigation is currently underway.Upon completion, the results will be forwarded.
Event or Problem Description
The customer reported that during the pre-use check, when the physician tried to draw the saline into 3cc syringes for inflating the balloon, leakage happened from the syringe.As the syringe had cracked, it was unable to use.Another syringe in the hospital instead was used.
Additional Manufacturer Narrative
The device history record (dhr) for lot 926640 indicates that there were no failures in the samples visually and functionally tested during manufacturing and no non-conformances were generated in the production of this product.A review of maintenance records (both corrective and preventive) and calibration records were reviewed and there were no issues relating to the reported issue.There were no related process or material changes related to the reported condition for this product or describe changes that occurred.Process monitoring data was reviewed for the production dates of the lot and no abnormalities were identified relating to this issue.A review of the machine setup was conducted, and no issue were observed.A sample and pictures were reviewed, and the reported issue was confirmed.However, based on all available information, the exact root cause could not be identified.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 lot met all defined acceptance requirements and was released.In conclusion, the investigation did not identify a systemic issue with the product or process, no trend exists for the reported issue, and a specific root cause could not be identified based on available information.Therefore, a corrective and preventive action (capa) is not necessary at this time.A quality alert will be generated and communicated to the syringe department for awareness.This complaint will be used for tracking and trending purposes.

• Brand Name: MONOJCT 3ML SYR L-LOCK BNS
• Common Device Name: SYRINGE, PISTON
• Manufacturer (Section D): CARDINAL HEALTH; 2010 east international speedw; deland FL 32724
• 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: 13716208
• Report Number: 1017768-2022-01001
• Device Sequence Number: 20404963
• Product Code: FMF
• UDI-Device Identifier: 10884521030886
• UDI-Public: 10884521030886
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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): 06/14/2022

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
• Operator of Device: Health Professional
• Device Model Number: 8881103066
• Device Catalogue Number: 8881103066
• Device Lot Number: 926640
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/28/2022
• Supplement Date Received by Manufacturer: 02/28/2022
• Initial Report FDA Received Date: 03/09/2022
• Supplement Report FDA Received Date: 06/14/2022
• Date Device Manufactured: 09/20/2019
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown