MAUDE Adverse Event Report: MEDSOURCE LABS LLC PREMIER PRO; TRUESAFE COMFORT 20G X 1.16" PUR

Model Number	31T20116
Medical Device Problem Code	Component Misassembled (4004)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/10/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The batch manufacturing records (bmr) for the reported batch was reviewed.No non-conformities related to the complaint were observed.Reports were verified for any supplier or raw material changes.No changes were incorporated in the process or material.No non-conformities related to the reported complaint were observed during the visual inspection and functional testing of the control samples of 31t20116; lot: dun0840657/0402.The affected product was not returned for investigation.Therefore, control samples of the lot reported were used for testing.The following tests were performed on the control samples to investigate the reported complaint: 1.Visual inspection: no visual defects observed.2.Safety mechanism test: no defect observed (metallic spring proper assembled) 3.Pull force between gauge chamber & front chamber : as per the specification 4.Needle pull test : as per the specification since the problem was not observed during the inspection of control samples, all concerned personnel have been made aware of the reported complaint and instructed to monitor the manufacturing process effectively.The reported complaint may be related to manufacuring defects and user error with the following possibilities: · may be due to miss handling of the product.· product may not have been adequately inspected.· component may not have been assembled correctly.· inadequate assembly of the safety mechanism system.Based on the root cause analysis and the results obtained from the tests carried out on control samples of the reported batch, it is concluded that the product does not contain a manufacturing defect.This might be one time issue as the proper controls are already provided during manufacturing of products.Since it is a customer complaint, the same has been communicated to all relevant persons for effective monitoring of manufacturing process related to the reported complaint.
Event or Problem Description
I was starting an iv on a patient, and when i hit the needle retract button, the needle flew out the back end and hit me in the leg.I did not see any marks that make me think the needle stuck me, i am pretty certain i got hit with the back end of the needle.

• Brand Name: PREMIER PRO
• Common Device Name: TRUESAFE COMFORT 20G X 1.16" PUR
• Manufacturer (Section D): MEDSOURCE LABS LLC; 8600 shelby ct; chanhassen MN 55317
• Manufacturer Contact: neeraj gupta ; udyog vihar sector 18; grugram, haryana 11201-5 ; IN 112015
• MDR Report Key: 21182150
• Report Number: 3003674698-2025-00872
• Device Sequence Number: 4262831
• Product Code: FOZ
• UDI-Device Identifier: 00811220034528
• UDI-Public: 00811220034528
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K161779
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 01/16/2025

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: 31T20116
• Device Catalogue Number: 31T20116
• Device Lot Number: DUN0840657/0402
• 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: 12/10/2024
• Initial Report FDA Received Date: 01/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/31/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown