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

Model Number	3CC LL 22G*1 1/2
Medical Device Problem Code	Loose or Intermittent Connection (1371)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/10/2024
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
The customer stated the needle is coming off while they're injecting their patient.

• Brand Name: HENRYSCHEIN
• 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: 20328685
• Report Number: 3005405146-2024-00071
• Device Sequence Number: 7836060
• Product Code: FMF
• UDI-Device Identifier: 00304040002964
• UDI-Public: 00304040002964
• 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: 3CC LL 22G*1 1/2
• Device Catalogue Number: 112-7105
• Device Lot Number: 20231015, 20230405
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/10/2024
• Initial Report FDA Received Date: 09/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/26/2023
• 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