MAUDE Adverse Event Report: CARDINAL HEALTH MONOJCT 35ML SYR L-LOCK; SYRINGE, PISTON

Model Number	1182000777
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
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 the 35ml luer lock tips are breaking.Some in pieces and some completely at the connection to the syringe barrel.The problem has caused medication waste.Per additional information provided on december 07, 2022, the medication used at the time of the breaks is variable but most commonly is cefazolin, ceftriaxone, or cefepime.There has been no patient or user harm associated with the breaks.They use b braun¿s red tamper evident cap to cap these syringes.
Additional Manufacturer Narrative
The device history record was reviewed for lot 932903x and indicated that the product was released accomplishing all quality standards.The product was packaged between november 03-04, 2019.There were no photos or physical samples received for the investigation.Because a sample was not returned, we were unable to perform functional and visual evaluations to confirm the reported condition or determine the root cause.If a sample is received at a later date, the complaint will be reopened, and the investigation will be updated accordingly.Control mechanisms are in place to prevent the occurrence and acceptance of the reported condition during molding, printing, assembly, and packaging processes, and to ensure components and finished product meet all quality inspection standards during the syringe assembly processes.Per procedure, complaint trends are evaluated during monthly corrective and preventive action (capa) meetings to determine if a capa is warranted.At this time, there is not enough information and a capa will not be initiated.This complaint will be used for tracking and trending purposes.
Additional Manufacturer Narrative
Section d4: model and catalog number corrected to 1182000777 and unique identifier (udi) # corrected to (b)(4).Corrected product number was provided by the customer on december 20, 2022.

• Brand Name: MONOJCT 35ML SYR L-LOCK
• Common Device Name: SYRINGE, PISTON
• Manufacturer (Section D): CARDINAL HEALTH; 777 west street; mansfield MA 02048
• Manufacturer (Section G): CARDINAL HEALTH; 1222 sherwood rd; norfolk NE 68701
• Manufacturer Contact: jill saraiva ; 777 west street; mansfield, MA 02048 ; 5086183640
• MDR Report Key: 15942841
• Report Number: 1915484-2022-01306
• Device Sequence Number: 6210257
• Product Code: FMF
• UDI-Device Identifier: 10192253034677
• UDI-Public: 10192253034677
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/18/2023

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: 1182000777
• Device Catalogue Number: 1182000777
• Device Lot Number: 932903X
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/22/2022
• Supplement Date Received by Manufacturer: 11/22/2022; 11/22/2022
• Initial Report FDA Received Date: 12/08/2022
• Supplement Report FDA Received Date: 01/05/2023; 01/18/2023
• 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