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U.S. Department of Health and Human Services

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

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SOL-MILLENNIUM MEDICAL INC. TECHLITE INSULIN SYRINGE SYRINGE, PISTON Back to Search Results
Model Number 260314
Device Problem Product Quality Problem (1506)
Patient Problem Needle Stick/Puncture (2462)
Event Date 05/28/2021
Event Type  malfunction  
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 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.
 
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Brand NameTECHLITE INSULIN SYRINGE
Type of DeviceSYRINGE, 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 Key12035517
MDR Text Key263566314
Report Number1832816-2021-00013
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K153537
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation Pharmacist
Type of Report Initial
Report Date 05/29/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/21/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number260314
Device Catalogue Number260314
Device Lot Number02909043
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/29/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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