MAUDE Adverse Event Report: RETRACTABLE TECHNOLOGIES, INC. 25G X1 EASY POINT NEEDLE; NEEDLE, HYPODERMIC, SINGLE LUMEN

Catalog Number	82011
Health Effect - Clinical Code	Exposure to Body Fluids (1745)
Date of Event	07/14/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
Tuesday july 14th at approximately 3:00pm an rn from the (b)(6) clinic from (b)(6) health medical services was administering a vaccine to a patient.After performing the intramuscular injection the rn attempted to engage the innate safety mechanism to sheath the needle.After applying pressure the rn's hand slipped and lacerated their left upper thigh.The rn immediately washed the affected area and placed a band-aid on the wound.The rn immediately notified the infection control nurse and the director of nursing.The nurse visited (b)(6) health for medical treatment.Their ppe consisted of a surgical mask, gloves and face shield.Eh&s is investigating the 25g x1" easypoint needle's failure to notify the manufacturer of the malfunctioning device.The lot number is k128a.Expiration: 4/28/2024, manufacturer easypoint.Reporting on behalf of injured nurse from (b)(6) university (b)(6) medical center occupational services who injured themselves attempting to engage engineered sharp after performing investigation.Phi regarding testing was not provided although personnel potentially exposed to bbp are offered post exposure prophylaxis and undergo baseline serology as part of (b)(6) medical surveillance.The er most likely follows the same procedures.Fda safety report id #(b)(4).

• Brand Name: 25G X1 EASY POINT NEEDLE
• Common Device Name: NEEDLE, HYPODERMIC, SINGLE LUMEN
• Manufacturer (Section D): RETRACTABLE TECHNOLOGIES, INC.
• MDR Report Key: 10407229
• Report Number: MW5096068
• Device Sequence Number: 14340744
• Product Code: FMI
• UDI-Device Identifier: 00613703820129
• UDI-Public: 0613703820129
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Patient
• Type of Report: Initial
• Report Date (Section B): 08/11/2020

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 Expiration Date: 04/28/2024
• Device Catalogue Number: 82011
• Device Lot Number: K128A
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/13/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization