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

Model Number	SYRINGE/NDL, LL 3CC 20GX1"
Medical Device Problem Code	Device Contaminated During Manufacture or Shipping (2969)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/13/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Upon receipt of the customer complaint, kdl performed investigations including retained sample test and process review.
Event or Problem Description
Vaccine doses drawn up in these syringes and appear to have foreign body debris inside.The appearance is not consistent with normal vaccine precipitate.

• 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: 20166823
• Report Number: 3005405146-2024-00068
• Device Sequence Number: 12513212
• Product Code: FMF
• UDI-Device Identifier: 10612479207063
• UDI-Public: 10612479207063
• 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

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 20GX1"
• Device Catalogue Number: 16-SN3C201
• Device Lot Number: CKDC12-01
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/13/2024
• Initial Report FDA Received Date: 09/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/14/2023
• 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