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

Model Number	LL W/O NDL 1CC
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
Small cracks are found on the clear portion of several 1 cc syringes.
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.Then maintain complaint files in accordance with 21cfr part 803.18.

• Brand Name: MCKESSON
• Common Device Name: SYRINGE
• Manufacturer (Section D): SHANGHAI KINDLY ENTERPRISEDEVELOPMENTGROUP CO.,LTD; no. 658, gao chao rd., jiading; shanghai, shanghai 20180 3; CH 201803
• Manufacturer (Section G): SHANGHAI KINDLY ENTERPRISEDEVELOPMENTGROUP CO.,LTD; no. 658, gao chao rd., jiading; shanghai, shanghai 20180 3; CH 201803
• Manufacturer Contact: wendy yao ; no. 658, gao chao rd., jiading; shanghai, shanghai 20180-3 ; CH 201803
• MDR Report Key: 19266489
• Report Number: 3005405146-2024-00040
• Device Sequence Number: 6981598
• Product Code: FMF
• UDI-Device Identifier: 10612479217284
• UDI-Public: 10612479217284
• 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: Other
• Type of Report: Initial
• Report Date (Section B): 05/06/2024

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: LL W/O NDL 1CC
• Device Catalogue Number: 16-S1C
• Device Lot Number: CKDA09-01
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/20/2023
• Initial Report FDA Received Date: 05/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/03/2021
• 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