MAUDE Adverse Event Report: CARDINAL HEALTH 35ML LUER LOCK PHARMACY TRAY; SYRINGE, PISTON

Model Number	8881535101
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.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 (dhr) was reviewed, and no abnormal process conditions were present during the manufacturing of the product that could have led to the reported condition.The dhr review showed that all acceptance criteria inspections per established sampling levels were within acceptable limits during the production process.The device was manufactured on february 24, 2021.Sample analysis could not be performed as no photos or physical samples were received for evaluation.As a result, the reported condition could not be confirmed, and the root cause could not be determined.If a sample is received at a later date, the complaint will be reopened, and the investigation will be updated accordingly.A corrective action is not applicable at this time.We will continue to monitor customer complaint and feedback notifications for adverse trends that require immediate attention.This complaint will be used for tracking and trending purposes.

• Brand Name: 35ML LUER LOCK PHARMACY TRAY
• Common Device Name: SYRINGE, PISTON
• Manufacturer (Section D): CARDINAL HEALTH; 777 west street; mansfield MA 02048
• Manufacturer (Section G): CARDINAL HEALTH; calle 9 sur no. 125 cuidad ind; tijuana 22500 ; MX 22500
• Manufacturer Contact: jill saraiva ; 777 west street; mansfield, MA 02048 ; 5086183640
• MDR Report Key: 15943422
• Report Number: 9612030-2022-03488
• Device Sequence Number: 20431804
• Product Code: FMF
• UDI-Device Identifier: 20192253030737
• UDI-Public: 20192253030737
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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
• Report Date (Section B): 12/19/2022

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: 8881535101
• Device Catalogue Number: 8881535101
• Device Lot Number: 2104805664
• 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: 12/07/2022
• Supplement Date Received by Manufacturer: 12/07/2022
• Initial Report FDA Received Date: 12/08/2022
• Supplement Report FDA Received Date: 12/19/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/24/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown