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

Model Number	SYRINGE/NDL, LL 3CC 23GX1"
Medical Device Problem Code	Partial Blockage (1065)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/05/2023
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 the syringe plunger was getting stuck ? - ? way down the syringe while administering an injection and the injection could not be completed.The injection had to be discontinued.The customer indicated that there was no issue with drawing up the medication into the syringe and there was no concern of inaccurate dosage being injected when this issue occurred.No information was received regarding any serious injury as a result of this report.

• 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: 19266441
• Report Number: 3005405146-2024-00027
• Device Sequence Number: 7430873
• Product Code: FMF
• UDI-Device Identifier: 10612479207186
• UDI-Public: 10612479207186
• 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/NDL, LL 3CC 23GX1"
• Device Catalogue Number: 16-SN3C231
• Device Lot Number: CKDB03-02
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/27/2023
• Initial Report FDA Received Date: 05/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/02/2022
• 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