MAUDE Adverse Event Report: SOL-MILLENNIUM MEDICAL INC. SOL-M 1ML LUER LOCK SYRINGE W/O NEEDLE

Model Number 180001

Device Problems Gas/Air Leak (2946); Physical Resistance/Sticking (4012)

Patient Problem Hemorrhage/Bleeding (1888)

Event Type  Injury  

Manufacturer Narrative

Preliminary investigation analysis at sol-millennium supplier: batch review: production site checked the batch record of impacted sol-m luer lock syringe w/o needle ref 180001, lot 01002002.The lot passed testing and there were no deviations noted.The batch was produced on 2020.04.07, using the standard process.Analysis at sol-millennium: status of samples at end user is unknown.Device involved in the incident was not returned for evaluation.Sol-millennium has requested unused samples from ref 180001, lot 01002002 from the distributor molnlycke healthcare.Samples have been returned to sol-millennium and investigation is in progress.Results of investigation will be submitted in a follow up medwatch report by the due date of 2021-01-27.

Event Description

Distributor ((b)(4)) forwarded an adverse event complaint report from an end user (opthalmologist) to sol-millennium on 2020-11-27.Per the report, the sol-m 1 ml luer lock syringe piston is completely fixed (stuck) and it was difficult to get the contents out.When the syringe piston is released, the contents came out with tremendous force.A patient who had undergone an eye operation at the end user facility started bleeding from the iris (inside the eye) when the syringe contents were released with force.Per the customer therapy was delayed due to the incident however no additional patient follow up was needed.Per the end user customer, the problem is with resistance within the sol-m 1 ml syringes when aspirating/irrigating.It was not possible to create a controlled soft flow of the solutions out of the syringes.A second syringe was also affected with the same issue per the end user (syringe piston slides too slowly, and once contents come out, it comes out with a splash).It was also difficult to get the air out of the syringes.

Manufacturer Narrative

Additional manufacturer narrative on sample testing added in this follow up report submitted on 1/27/2021: background: this product model# 180001-sol-m 1ml luer lock syringe w/o needle (polycarbonate) is distributed as part of a kit pack by molnlycke healthcare under their ce mark in the eu region.Model#180001 is not sold as part of a kit pack in the united states (usa).Sol-millennium has in addition has not sold any syringes from model#180001 in the last two years (2019 and 2020) in the united states.Sol-millennium luer lock syringe - intended use : the invirostripe 1 ml standard luer lock hypodermic syringes are used to inject medicines and vaccines into, or withdraw fluids from, the body.Sample evaluation: actual device involved in the adverse event was not received for evaluation.Unused samples from lot 01002002 were received from (b)(6) healthcare for testing.Based on the batch size, per iso 2859-1- special inspection level s-4, sample size of (b)(4) of the received unused samples from lot 01002002 was selected for testing.The syringes were tested according to iso 7886-1:2017 annex e "test method for the determination of forces required to operate the piston".During the test, a mechanical testing machine was used to expel water from a syringe and simultaneously record the force required to move the piston.The test speed required was set at 100mm/min as specified in iso 7886-1:2017 annex e.In particular, the forces required to initiate movement of the piston and sustain the travel of the piston were recorded.The test was started 30 seconds after filling the syringe with water.The initial force to move the piston was important to note for the reported issue.Per iso 7886-1:2017 annex e, table e, for 1 ml capacity syringe, (v<2ml), the initial force to move the piston must be lower than 10n.The mean force must be lower than 5 n.The maximum force must be lower than twice the mean force or mean force plus 1.5 n whichever value is higher.All the (b)(4)tested from lot 01002002 were in compliance with iso 7886-1:2017 annex e.The initial force, mean force and maximum force values for the syringes tested were within the specification limits noted in the iso 7886-1:2017 annex e.In addition, the same above described test per iso 7886-1:2017 annex e "test method for the determination of forces required to operate the piston" was performed on a second lot, lot 19041124 from the same product (ref 180001).These samples were received from sol-millennium warehouse for testing by investigator.Sampling plan was according to iso 2859-1 - special inspection level s-4 and therefore a total (b)(4) were selected for testing.All the 80 samples from lot 19041124 were in compliance with iso 7886-1:2017 annex e.The initial force, mean force and maximum force values for the syringes tested from this lot were also within the specification limits noted in the iso 7886-1:2017 annex e.Track and trend: a review of complaints of the last two years reveals that four complaints in total were received on ref 180001 sol-m 1ml luer lock syringe w/o needle (pc) for push/draw issue in the last two years.The three other complaints reported for the same issue are not associated with any patient or healthcare worker injury.Conclusion: samples of lot 01002002 that were tested were in compliance with iso 7886-1:2017 annex e "test method for the determination of forces required to operate the piston".In particular, the initial force to move the piston does not exceed the iso limits.Additionally, the results of lot 19041124 were in compliance with iso 7886-1:2017 annex e "test method for the determination of forces required to operate the piston".

• Brand Name: SOL-M 1ML LUER LOCK SYRINGE W/O NEEDLE
• Type of Device: SYRINGE
• Manufacturer (Section D): SOL-MILLENNIUM MEDICAL INC.; 315 shawnee north dr.; suite 100; suwanee GA 30024
• MDR Report Key: 11074184
• MDR Text Key: 229816058
• Report Number: 3014312726-2020-00004
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• PMA/PMN Number: K101359
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Type of Report: Initial,Followup
• Report Date: 01/27/2021

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?: No
• Device Operator: Health Professional
• Device Model Number: 180001
• Device Lot Number: 01002002
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/27/2020
• Initial Date FDA Received: 12/27/2020
• Supplement Dates Manufacturer Received: 11/27/2020
• Supplement Dates FDA Received: 01/27/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other