MAUDE Adverse Event Report: U.S. SURGITECH INC SURGYNEEDLE; NEEDLE, ASPIRATION AND INJECTION, DISPOSABLE

Model Number	780-412
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/10/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The customer emailed a complaint that the surgyneedle product (item 780-412) was leaking during a procedure.
Additional Manufacturer Narrative
U.S.Surgitech received a complaint about the leakage from its customer.The suspect devices were returned for the evaluation.It appears that the plastic tube had micro cracks in it and leading to leaking issue.The micro cracks could be appeared due to thr force used to assemble the plastic tube and the needle hub.It was the first and only time we hear about this issue from any customer.The contract manufacturer is assembling the plastic tube and needle hub by using a glue so that both components of the device are assembled permanently causing no loosening or micro cracks appearance causing the leaking issue.After implementing the corrective action, the problem is resolved as no leakage issues were complaint afterwards, therefore, u.S.Surgitech inc considers this complaint closed.Note (confidential): during the fda inspection there was an observation by the investigator that this complaint was reportable and was not reported at that time.Therefore, u.S.Surgitech inc is following the due diligence and reporting it to fda.

• Brand Name: SURGYNEEDLE
• Common Device Name: NEEDLE, ASPIRATION AND INJECTION, DISPOSABLE
• Manufacturer (Section D): U.S. SURGITECH INC; 551 kimberly drive; carol stream; chicago IL 60188
• Manufacturer (Section G): HANGZHOU TONGLU SHIKONGHOU MEDICAL INSTRUMENTS CO.; 100 sangyuan raod, tonglu; hangzhou; tonglu, zhejiang 31150 0; CH 311500
• Manufacturer Contact: hammad yousaf ; 551 kimberly drive; carol stream; chicago, IL 60188 ; 8009704877
• MDR Report Key: 20115605
• Report Number: 3004777218-2024-00005
• Device Sequence Number: 7220978
• Product Code: GAA
• UDI-Device Identifier: 00810014635118
• UDI-Public: 00810014635118
• Combination Product (Y/N): N
• Initial Reporter State: IA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/01/2024

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: 08/05/2023
• Device Model Number: 780-412
• Device Catalogue Number: 780-412
• Device Lot Number: 20190421
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/10/2022
• Initial Report FDA Received Date: 09/01/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/20/2023
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown