MAUDE Adverse Event Report: JIANGSU CAINA MEDICAL CO.,LTD MCKESSON BRANDS; SYRINGE, INSULIN 1CC 29GX1/2"

Catalog Number	102-SN1C2905P
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); Skin Inflammation/ Irritation (4545)
Date of Event	06/26/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported by the customer that the needle broke off from the syringe/hub while in use on a patient.Forceps were required to retrieve the needle from the patient's skin.There was noted skin irritation post retrieval.This was reported to have happened more than once from separate boxes with the same lot number.

• Brand Name: MCKESSON BRANDS
• Common Device Name: SYRINGE, INSULIN 1CC 29GX1/2"
• Manufacturer (Section D): JIANGSU CAINA MEDICAL CO.,LTD; no.23 huanxi rd; zhutang town; jiangyin city, jiangsu ; CH
• MDR Report Key: 19804308
• Report Number: 1451040-2024-00036
• Device Sequence Number: 18079906
• Product Code: FMF
• UDI-Device Identifier: 20612479187881
• UDI-Public: 20612479187881
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/23/2024
• Report Date (Section F): 07/23/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 102-SN1C2905P
• Device Lot Number: CJCB05-01
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 06/26/2024
• Device Age: 25 MO
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 07/23/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/23/2024
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown
• Date Report Sent to FDA: 07/23/2024