MAUDE Adverse Event Report: JIANGSU CAINA TECHNOLOGY CO., LTD. COMFORT TOUCH INSUIN PEN NEEDLES; NEEDLE, HYPODERMIC, SINGLE LUMEN

Model Number	INSULIN PEN NEEDLES
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/20/2021
Type of Reportable Event	Malfunction
Event or Problem Description
Confusion about wrong label; (b)(4) are distributing unapproved size 33g insulin pen needles.A 510k data for shows approved only for 29g, 30g, 31g, 32g.Fda 510k # is k170846.Poor flow of insulin due to needle being thin is obstructive and not sufficient.Fda safety report id # (b)(4).

• Brand Name: COMFORT TOUCH INSUIN PEN NEEDLES
• Common Device Name: NEEDLE, HYPODERMIC, SINGLE LUMEN
• Manufacturer (Section D): JIANGSU CAINA TECHNOLOGY CO., LTD.
• MDR Report Key: 11870001
• Report Number: MW5101500
• Device Sequence Number: 11683892
• Product Code: FMI
• UDI-Device Identifier: 00850024759053
• UDI-Public: 00850024759053
• Initial Reporter State: FL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: No Information
• Type of Report: Initial
• Report Date (Section B): 05/20/2021
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: No Information
• Device Model Number: INSULIN PEN NEEDLES
• Device Catalogue Number: 33G, 4MM, 5/32
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/21/2021
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 51 YR
• Patient Weight: 85