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

Model Number	SYRINGE/NDL, LL 10CC 20GX1"
Medical Device Problem Codes	Break (1069); Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/15/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The customer claims that the flanges were breaking.Also noted the plunger becomes loose and losses pressure if used more than 2 times.
Additional Manufacturer Narrative
Upon receipt of the customer complaint, kdl performed investigations including retained sample test and process review.

• 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: 20166839
• Report Number: 3005405146-2024-00069
• Device Sequence Number: 7058417
• Product Code: FMF
• UDI-Device Identifier: 10612479207032
• UDI-Public: 10612479207032
• 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 10CC 20GX1"
• Device Catalogue Number: 16-SN10C201
• Device Lot Number: CKDD03-01
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/15/2024
• 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