MAUDE Adverse Event Report: SOL-MILLENNIUM MEDICAL INC. DROPLET INSULIN SYRINGE 31G X 6MM 0.5ML; SYRINGE, HYPODERMIC NEEDLE

Model Number	0.5ML, 31 X 6MM
Medical Device Problem Codes	Complete Blockage (1094); No Flow (2991)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/04/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The complaint device was returned for evaluation to sol-millennium r&d department received 2pcs of defective samples and unused samples of complained htl/droplet 0.5ml insulin syringe 31g x 6mm (u-100 insulin only)(pe bag), ref 6002, lot 02107171 for evaluation.The 2pcs of defective samples have been visually checked using an optical microscope under magnification 50x.In one of them it is possible to see a translucent foreign material inside the cannula lumen, while in the other one no visible foreign material is visible.The foreign material present in defective sample 1 was analyzed by ftir infrared spectroscopy, while it was not possible to analyze the foreign material present in defective sample 2 due to reduced qty extractable.Risk statement: clogged-cannula: the overall risk assessment, given the severity assessment of s2-minor injury and a probability assessment of p2-low, the final risk priority number is ]4.Risk level of this specific hazard is in green area/low risk.Detached/loose-cannula: the overall risk assessment, given the severity assessment of s3-moderate injury and a probability assessment of p2-low, the final risk priority number is 6.Risk level of this specific hazard is in green area/low risk.
Event or Problem Description
On(b)(6)2022 htl-strefa registered a complaint from the customer (htl-strefa s.A.Ref.No.: (b)(6)2022).Below full description of the notification: "patient received 3 boxes of droplet insulin syringes 31g x 6mm 0.5ml from humana with lot number: 02107171.Patient is fairly new to the droplet brand and has been using bd syringes for roughly 20 years.The patient claims that the needles "have no hole in them," so that he cannot draw insulin.He has tried drawing water as well, but he was unable to.He claims that when he pulls the plunger back, the needle tip is pulled into the syringe.He has had this issue with 2 needles in one of the boxes.We are sending 4 replacement boxes as a courtesy and are expecting samples." the complaint was forwarded to the manufacturer (b)(4).Customer sample was returned to htl-strefa s.A.On (b)(6)2022 and re-send to the manufacturer for the further analysis.The results of the retained sample evaluation was provided on (b)(6)2022 as complaint official final response letter comp(b)(4).The archival samples evaluation did not reveal any nonconformities that could contribute to arising complained defects and no anomalies found on batch documentation.The results of the customer sample evaluation was provided on (b)(6)2023 as comp-(b)(4)_addendum.Sample received by the customer confirmed the complained issue, clogged-cannula.The ftir infrared spectroscopy analysis confirm the clogged element is an excess of silicone oil.

• Brand Name: DROPLET INSULIN SYRINGE 31G X 6MM 0.5ML
• Common Device Name: SYRINGE, HYPODERMIC NEEDLE
• Manufacturer (Section D): SOL-MILLENNIUM MEDICAL INC.; 315 shawnee north drive; suite 100; suwanee GA 30024
• Manufacturer (Section G): SOL-MILLENNIUM MEDICAL INC; 315 shawnee north drive; suite 100; suwanee GA 30024
• Manufacturer Contact: shari wiley ; 315 shawnee north drive; suite 100; suwanee, GA 30024 ; 8336370857
• MDR Report Key: 16314799
• Report Number: 3014312726-2023-00001
• Device Sequence Number: 6327376
• Product Code: FMI
• UDI-Device Identifier: 05907996095599
• UDI-Public: 05907996095599
• Combination Product (Y/N): N
• Initial Reporter Country: PL
• PMA/510(K) Number: K153537
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 01/17/2023

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: Lay User/Patient
• Device Expiration Date: 08/10/2026
• Device Model Number: 0.5ML, 31 X 6MM
• Device Catalogue Number: 6002
• Device Lot Number: 02107171
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/27/2022
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/17/2023
• Initial Report FDA Received Date: 02/07/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/10/2021
• 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 Sex: Male