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

Model Number	10ML LL
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
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.Then maintain complaint files in accordance with 21cfr part 803.18.
Event or Problem Description
The customer had multiple syringes crack down the side while flushing ivs, it was not even a forceful injection, it sprays the syringe content all over the clinical practitioner and the patients.

• 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: 19266499
• Report Number: 3005405146-2024-00044
• Device Sequence Number: 15230776
• Product Code: FMF
• UDI-Device Identifier: 10612479206882
• UDI-Public: (01)10612479206882
• 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): 05/06/2024

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: 10ML LL
• Device Catalogue Number: 16-S10C
• Device Lot Number: CKDB07-04
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/16/2024
• Initial Report FDA Received Date: 05/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/19/2022
• 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