MAUDE Adverse Event Report: CARDINAL HEALTH MONOJCT 60ML SYR L-LOCK RP; SYRINGE, PISTON

Model Number	8881560125
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/14/2023
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 they ordered 25 cases and received it on march 14, 2023.Upon inspection, they noticed that 7 pcs of have broken tips and cannot be used.
Additional Manufacturer Narrative
The manufacturing site received six photographs for product analysis.Photo 1 shows the top portion of a luer lock syringe with grey plunger rod and rubber tip.The outside diameter of the luer skirt appears to have skived plastic material.Photo 2 shows the top portion of a luer lock syringe with grey plunger rod and rubber tip.The luer tip is either missing or broken.Photo 3 shows the top portion of a luer lock syringe with grey plunger rod and rubber tip.Slight damage on the luer skirt can be observed.Photo 4 shows the top portion of a luer lock syringe with grey plunger rod and rubber tip.Damaged luer skirt and damaged/bent luer tip can be observed.Photo 5 shows the top portion of a luer lock syringe with grey plunger rod and rubber tip.Damaged luer skirt and damaged/bent luer tip can be observed.Photo 6 shows the top portion of a luer lock syringe with grey plunger rod and rubber tip.Damaged luer skirt and damaged/bent luer tip can be observed.Additionally, the manufacturing site received seven unpackaged 60ml luer lock syringes for product analysis.A complete investigation was performed.Visual inspection to the quality inspection standard was conducted.The luer tip was broken off near the base of the syringe barrel face on one of the syringe samples.Damaged luer skirt and bent/damaged luer tip was identified on three of the syringe samples.Slight damage/skived plastic on the luer skirt was identified on two of the syringe samples.Incomplete fill was observed on the inside rib on the molded plunger rod on one of the syringe samples received.Based on the photos and physical samples there were analyzed the reported issue was confirmed.The device history record (dhr) for lot 208741x was reviewed.During the manufacturing of the syringe assemblies, syringes were visually inspected and physically tested with no failures recorded relating to the reported issue.The molded barrels inspection reports were reviewed with no issues recorded relating to the reported condition.The dhr for the lot control indicates that product and specification requirements were met with no non-conforming product identified relating to this customer report.Based on the available information, an exact root cause for the damaged luer tips and luer skirts were not determined.No corrective actions are required at this time.However, the reported condition will be communicated to the appropriate quality and manufacturing personnel.This case will be used for tracking and trending purposes.

• Brand Name: MONOJCT 60ML SYR L-LOCK RP
• Common Device Name: SYRINGE, PISTON
• Manufacturer (Section D): CARDINAL HEALTH; 777 west street 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: 16628803
• Report Number: 1915484-2023-01311
• Device Sequence Number: 17470620
• Product Code: FMF
• UDI-Device Identifier: 20884521012230
• UDI-Public: 20884521012230
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/10/2023

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: 8881560125
• Device Catalogue Number: 8881560125
• Device Lot Number: 208741X
• 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: 03/24/2023
• Supplement Date Received by Manufacturer: 03/24/2023
• Initial Report FDA Received Date: 03/28/2023
• Supplement Report FDA Received Date: 05/10/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/16/2022
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown