MAUDE Adverse Event Report: CARDINAL HEALTH 3ML LUER LOCK PHARMACY TRAY; SYRINGE, PISTON

Model Number	8881513207
Medical Device Problem Codes	Break (1069); Crack (1135)
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 that during inspection of lot 2209408764, several syringes were rejected for particulate matter on the plunger and broken syringes, leading to the lot failing inspection.A photo provided shows the breaks the customer is referring to are a broken luer tip, a cracked barrel, and a broken finger flange.
Additional Manufacturer Narrative
There were four photos and twelve physical samples received for investigation.The samples were visually inspected, and the reported conditions were confirmed.One syringe had a broken tip and eleven syringes had particles in the plunger.The device history record was reviewed, and no abnormal process conditions were present during the manufacturing of the product that could have led to the reported conditions.The dhr review showed that all acceptance criteria inspections per established sampling levels were within acceptable limits during the production process.The product was manufactured on april 13, 2022.A gemba walk was performed at the manufacturing line and the current process and controls were found properly followed including finished product assembly, packaging, and inspections performed to the product.In addition, qc inspections are performed to the product for material release and production personnel performs a 100% visual inspection during the packaging process in order to detect and discard any identified issues.Based on all available information, a root cause related to the manufacturing process could not be determined.However, the appropriate production personnel did receive an alert notification to heighten awareness of this report.This complaint will be used for tracking and trending purposes.

• Brand Name: 3ML 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: 15159624
• Report Number: 9612030-2022-03342
• Device Sequence Number: 12128537
• Product Code: FMF
• UDI-Device Identifier: 20192253030690
• UDI-Public: 20192253030690
• 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): 08/30/2022

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: 8881513207
• Device Catalogue Number: 8881513207
• Device Lot Number: 2209408764
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/03/2022
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/14/2022
• Supplement Date Received by Manufacturer: 07/14/2022
• Initial Report FDA Received Date: 08/03/2022
• Supplement Report FDA Received Date: 08/30/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/13/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown