MAUDE Adverse Event Report: RETRACTABLE TECHNOLOGIES, INC. EASYPOINT NEEDLE; HYPODERMIC NEEDLE

Model Number	25 X 5/8
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	11/09/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Initial report of needle separation in patient was submitted by vaccine manager of user facility on november 9, 2023.The initial information was reported as follows: nurse gave flue vaccine in child's thigh.When she went to retract the needle it went inside of the patient's thigh.The patient went to hospital and had to have it removed vaccine manager reported that facility did not retain involved product but had associated product.Shipping containers were sent for return of associated product and receipt was confirmed on november 17, 2023.November 17, 2023 reporting vaccine manager to follow up regarding treatment and outcome of patient involved in the incident.Associated product was received and testing was completed on december 28, 2023.All samples returned were tested and were within specification.Vaccine manager provided follow up information on november 29, 2023 stating that the patient's mother returned to the hospital and the needle was surgically removed by the hospital.The same day vaccine manager provided an image of a detached needle, an xray of needle in patient's thigh and an xray that shows no needle.On december 19, 2023 the vaccine manager reported that no further information could be provided."the needle was in the patient's leg, he went to the hospital and had it surgically removed and we do not have the product".
Event or Problem Description
Initial report of needle separation in patient was submitted by vaccine manager of user facility on (b)(6) 2023.The initial information was reported as follows: nurse gave flue vaccine in child's thigh.When she went to retract the needle it went inside of the patient's thigh.The patient went to hospital and had to have it removed vaccine manager reported that facility did not retain involved product but had associated product.Shipping containers were sent for return of associated product and receipt was confirmed on (b)(6) 2023.(b)(6) 2023 reporting vaccine manager to follow up regarding treatment and outcome of patient involved in the incident.Associated product was received and testing was completed on (b)(6) 2023.All samples returned were tested and were within specification.Vaccine manager provided follow up information on (b)(6) 2023 stating that the patient's mother returned to the hospital and the needle was surgically removed by the hospital.The same day vaccine manager provided an image of a detached needle, an xray of needle in patient's thigh and an xray that shows no needle.On (b)(6) 2023 the vaccine manager reported that no further information could be provided."the needle was in the patient's leg, he went to the hospital and had it surgically removed and we do not have the product.".

• Brand Name: EASYPOINT NEEDLE
• Common Device Name: HYPODERMIC NEEDLE
• Manufacturer (Section D): RETRACTABLE TECHNOLOGIES, INC.; 511 lobo lane; little elm TX 75068
• Manufacturer (Section G): JUMIN BIO-TECHNOLOGIES, CO LTD; 1888 huhang road; jianghai economic zone; fengxian, shanghai 20140 0; CH 201400
• Manufacturer Contact: michele larios ; 511 lobo lane; little elm, TX 75068 ; 9722941010
• MDR Report Key: 18539548
• Report Number: 1647137-2024-00001
• Device Sequence Number: 12379394
• Product Code: FMI
• UDI-Device Identifier: 00613703820907
• UDI-Public: 00613703820907
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K133635
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 01/18/2024

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 Model Number: 25 X 5/8
• Device Catalogue Number: 82091
• Device Lot Number: K220402
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/09/2023
• Supplement Date Received by Manufacturer: 11/09/2023
• Initial Report FDA Received Date: 01/18/2024
• Supplement Report FDA Received Date: 01/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/17/2022
• 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
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Unknown