MAUDE Adverse Event Report: SHANGHAI KINDLY ENTERPRISEDEVELOPMENTGROUPCO.,LTD MCKESSON; SYRINGE

Model Number	SYRINGE, LL 5CC
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/05/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Upon receipt of the customer complaint, kdl conducted an investigation that included retained sample testing and process review.Corrective and preventive action (capa) was initiated in a timely manner in accordance with relevant regulations and company documents to prevent recurrence of the problem.Maintain complaint files in accordance with 21cfr part 803.18.
Event or Problem Description
It was reported by the customer that during an injection, fluid began leaking out.It was discovered that the syringe had a crack on the side.A new syringe had to be drawn.

• Brand Name: MCKESSON
• Common Device Name: SYRINGE
• Manufacturer (Section D): SHANGHAI KINDLY ENTERPRISEDEVELOPMENTGROUPCO.,LTD; no.658, gaochao road,; jiading district,; shanghai, shanghai 20180 3; CH 201803
• Manufacturer (Section G): SHANGHAI KINDLY ENTERPRISEDEVELOPMENTGROUPCO.,LTD; no.658, gaochao road,; jiading district,; shanghai, shanghai 20180 3; CH 201803
• Manufacturer Contact: wendy yao ; no.658, gaochao road,; jiading district,; shanghai, shanghai 20180-3 ; CH 201803
• MDR Report Key: 19266427
• Report Number: 3005405146-2024-00023
• Device Sequence Number: 20690514
• Product Code: FMF
• UDI-Device Identifier: 10612479207001
• UDI-Public: 10612479207001
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K112057
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 05/07/2024

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: SYRINGE, LL 5CC
• Device Catalogue Number: 16-S5C
• Device Lot Number: CKDB08-02
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/18/2023
• Initial Report FDA Received Date: 05/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/11/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown