MAUDE Adverse Event Report: SOL-MILLENNIUM MEDICAL INC. TECHLITE INSULIN SYRINGE; SYRINGE, PISTON

Model Number	260314
Medical Device Problem Code	Product Quality Problem (1506)
Health Effect - Clinical Code	Needle Stick/Puncture (2462)
Date of Event	05/28/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product involved in incident was not returned for evaluation.If product is returned, arkray will send to manufacturer for testing and file a follow-up report when evaluation is complete.
Event or Problem Description
Part 260314.Lot 02909043.Exp date: 2024-10-20.Caller is claiming that she has four boxes of insulin syringes and that many of the syringes are uncapped within the packaging that holds the syringe and that many of the packages that hold the syringes are of low quality in her opinion and are ripped or damaged.Caller also claimed that she was showing a customer how to use the insulin syringe and that she was accidentally stuck by the needle during the demonstration and that the needle that stuck her was bent.Upon visual inspection of other needles in the packages she did not know if anymore were bent but claimed they could be bending because the caps are off on a lot of them.Since the caller was stuck with the needle, she did seek medical treatment as that is her company's policy for such an incident, and she did have a blood test performed to rule out any possible infections through blood borne pathogens, but the needle she was stuck with was a brand new needle out of the box and she was the only person who had used it, so the needle was sterile when it poked her.Caller stated that she did not sell any of these products to the customer that she was demonstrating it to, because she became concerned about the quality of the product.When offered a replacement for the boxes of syringes in question, caller refused replacement as she has decided that she will not be offering this brand of syringes to her customers.Caller will return the complaint boxes of syringes for further investigation.
Additional Manufacturer Narrative
Complaint devices involved in complaint were returned on 6/29/2021 and forwarded to the manufacturer for further investigation.Investigation results were received on 2/8/2022.Retains of devices were inspected and no anomalies were found.10 samples were returned by customer.7 out of 10 were out of product specification requirement with the cap not on the needle.Root cause was conducted, and the issue was determined to be caused by long-distance transportation vibration.Manufacturer has implemented a 100% check of product for cap position after package is sealed.This will help confirm all the products were capped and assembled properly before shipment.Risk assessment analysis is low based on sales of product and overall complaints, of which in the last year, there were three complaints related to this issue.No trend evidence.Complaints will continue to be monitored for indication of possible trend.

• Brand Name: TECHLITE INSULIN SYRINGE
• Common Device Name: SYRINGE, PISTON
• Manufacturer (Section D): SOL-MILLENNIUM MEDICAL INC.; 315 shawnee drive n suite 100; suwanee GA 30024
• Manufacturer (Section G): SOL-MILLENNIUM MEDICAL INC.; 315 shawnee drive n suite 100; suwanee GA 30024
• Manufacturer Contact: tom speikers ; 5182 w 76th street; minneapolis, MN 55439 ; 9526463168
• MDR Report Key: 12035517
• Report Number: 1832816-2021-00013
• Device Sequence Number: 4166585
• Product Code: FMF
• UDI-Device Identifier: 00015482613143
• UDI-Public: (01)00015482613143
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K153537
• 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: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 02/14/2022

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: 10/20/2024
• Device Model Number: 260314
• Device Catalogue Number: 260314
• Device Lot Number: 02909043
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/29/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 05/29/2021
• Supplement Date Received by Manufacturer: 05/29/2021
• Initial Report FDA Received Date: 06/21/2021
• Supplement Report FDA Received Date: 02/14/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/02/2019
• 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
• Patient Age: 37 YR
• Patient Sex: Female
• Patient Weight: 50 KG