MAUDE Adverse Event Report: SOL-MILLENNIUM MEDICAL INC. SOL-M 3 ML LUER LOCK SYRINGE W/O NEEDLE

Model Number P180003

Device Problems Failure of Device to Self-Test (2937); Material Protrusion/Extrusion (2979)

Patient Problems Hemorrhage/Bleeding (1888); Retinal Injury (2048)

Event Type  Injury  

Manufacturer Narrative

Sol-millennium evaluation: multiple attempts were made by sol-millennium to obtain samples from distributor ((b)(4)) however, status of samples at end user is unknown.No lot number was provided for the sol-m syringe as well as for the sterimedix needle that was used by the end user during the reported incident.As a result the investigation of the complaint was done based on retain samples of 5 lots sold to distributor (the 5 lots selected cover 83% of quantity sold to distributor).The 5 lots of sol-m syringes selected for investigation were: sku# 180003 lots 04911017, 18062709, 04910043, 04002020 and 19061311.Analysis at sol-millennium supplier: batch review results of sku# 180003 lots 04911017, 18062709, 04910043, 04002020 and 19061311: production site checked the batch records of the 5 lots and all lots passed testing and there were no deviations noted.Retain samples evaluation of sku# 180003 lots 04911017, 18062709, 04910043, 04002020 and 19061311: resistance to separation from axial load according to iso 80367-7:2016: five (5) pieces were tested for each batch.All samples passed the test.Resistance to separation from unscrewing according to iso 80367-7:2016: five (5) pieces tested for each batch.All samples passed the test.Resistance to overriding according to iso 80367-7:2016: five (5) pieces tested for each batch.All samples passed the test.Analysis at sol-millennium: torque test fixing the luer lock of syringe: sol-m syringe lot 04911017 (10 pieces) were tested with 10 pieces of sterimedix medical needles of same part number 2273e-03nsp but of a different lot (lot# 407442) with the needle cap placed on the needle, simulating customer use.After fixing the luer cone of 10 samples of syringe of lot 04911017 to the torque meter, the sterimedix hydrodissector needle with cap was screwed in to the syringe luer cone.The screw-in force and screw-out force values were recorded for 10 samples.The screw-in force should be between 8cnm to 12 cnm according to iso 80369-20 annex g - resistance to separation force from unscrewing.Screw-out force should be at least 1.9cnm according to iso 80369-7 § 6.5 - resistance to separation force from unscrewing.The sol-m investigator recorded screw-in force values of stermedix needle part number 2273e-03nsp that was assembled to the luer lock connector.The values were lower than 8cnm to 12 cnm, in particular we recorded an average value of 2.3cnm (minimum value was 1.7cnm).As a consequence, the screw-out forces recorded were also very low with an average value of 1.7cnm (minimum 0.98cnm).The low screw-in values resulting in low screw-out values were due to the absence of ribs on the sterimedix needle hub as well as on the needle cap thus allowing the cap to spin after connection to syringe.Per the investigator based on the simulation testing, it is likely that low screw-in force value applied by end user while connecting the sterimedix hydrodissector needle to the sol-m syringe resulted in the detachment of the needle during eye surgery.Torque test fixing the sterimedix needle (without needle cap): samples from 5 lots sku# 180003 lots 04911017, 18062709, 04910043, 04002020 and 19061311 were tested at r&d facility with sterimedix medical needles lot#407442.Five syringes from each lot (total 25 pieces) were tested with 10 pieces of sterimedix needles without needle cap.After fixing the sterimedix hydrodissector needle to the torque meter, 5pcs of each lot of luer lock syringes were screwed-in with a torque force range 10 - 10.5 n cm.While screwing the syringe on the needle hub, the investigator was able to apply a higher screw-in force since the needle cap was removed.The screw-in force and screw-out force values were recorded.The recorded values were higher than 1.9 cnm (minimum value according to iso (b)(4) § 6.5 resistance to separation force from unscrewing), in particular, investigator recorded an average of 7.98cnm and a minimum of 4.76 cnm.The connection between sterimedix hydrodissector needle and sol-m luer lock syringe was stable and a higher screw-out force was needed to detach the needle.This test was performed for investigative purposes to verify if the sterimedix needle hub by itself was compatible with syringe luer lock connection.Conclusion: the sol-m 3ml luer lock syringe w/o needle, ref p180003 passes all iso testing and functions as designed.Upon evaluation of sterimedix needle, it was determined that an absence of ribs on the needle hub and on the needle cap of sterimedix hydrodissector needle prevents the needle from securely attaching to the luer lock syringe.The needle cap spins during connection to syringe luer cone and the user is not able to screw-in the sterimedix hydrodissector needle to the luer cone of the syringe with adequate force resulting in detachment of needle from syringe during use.Sol-millennium is unable to determine a true root cause of the reported issue at this time because we believe the deficiency has been identified in another manufacturers product.We are awaiting information from the other manufacturer.Sol-millennium has learnt that distributor ((b)(4)) has reached out to sterimedix for investigation of the reported issue.Sol-millennium has reached out to the distributor to obtain results of the investigation done by sterimedix.Sol-millennium will evaluate the data from the sterimedix investigation to determine if further actions are needed.Sol-millennium will file a follow up report once the sterimedix investigation is received (by 01/31/2021).

Event Description

Distributor ((b)(4)) reported an end user customer complaint to sol-millennium on 10/22/2020.During cataract surgery the blunt cannula detached from the tip of the sol-m 3ml luer lock syringe pierced the capsule bag and hit the lower part of the retina.The cannula that was left in the eye was taken out.There was an injury to patient's retina and slight bleeding occurred inside the patient's eye.Medical or surgical intervention was required as a result since the patient eye was operated with laser the next day to repair a hole in the retina.Patient needed to be hospitalized an extra day but has since recovered from the incident.Per the end user the needle and syringe did not look defective.Molnlycke reported that cannula used is 2273e-03nsp from sterimedix supplier.The cannula was securely attached to syringe but when the drug was added during the surgery, the cannula detached.

Manufacturer Narrative

Updated information as of 1/31/2021: three attempts were made to obtain investigation results from sterimedix.Emails were sent to (b)(6) on 2020-11-19, 2020-11-24 and 2020-12-11 for obtaining sterimedix investigation results.No further information was received as of 2021-01-31.Sol-millennium will close this complaint investigation.The sol-m 3ml luer lock syringe w/o needle, ref p180003 passes all iso testing and functions as designed.No further corrective actions are required by sol-millennium.

• Brand Name: SOL-M 3 ML 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: 10881536
• MDR Text Key: 219309032
• Report Number: 3014312726-2020-00003
• 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: 11/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/21/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: P180003
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/22/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other