MAUDE Adverse Event Report: SOL-MILLENNIUM MEDICAL, INC SOL-M 5ML LUER LOCK SYRINGE W/O NEEDLE

Model Number 180005

Device Problem Loose or Intermittent Connection (1371)

Patient Problem Injury (2348)

Event Type  Injury  

Manufacturer Narrative

Sample was not received for evaluation.The production site checked the batch record of impacted sol-m 5ml luer lock syringe w/o needle, ref 180005, lot 19012409.The lot was produced on 04/08/2019 using the standard process with no anomalies found on batch documentation.Archive (retain) sample evaluation visual check: 10pcs of archived samples were selected to check the appearance of the luer lock connector.There were no deformities or damages found.Taper check: 10pcs of archived samples were checked with specific 6% cone jig.No anomalies were found.Needle screw test: 10 needles produced by the factory were combined with 10 archive samples of sol-m 5ml luer lock syringe.All the needles could be tightened without slipping.The factory also applied at least 0.15 nm (newton meter) torque to 5 pieces of archive samples of sol-m 5ml luer lock syringe for about 10 seconds to assemble its needles.No slipping effect was found.In addition, sol-millennium investigator performed simulation test using manufacturer hurricane's needles ref 2227 lot 190402 (same needle used by end user but of a different lot number) using a torque meter.The syringe was fixed in with a torque force range of 15 - 17 ncm (newton centimeter) for 5 seconds as per values reported in paragraph 6.6_resistance to overriding of iso 80369-7.The test is considered as pass if there is no sliding effect.All samples passed the test with no sliding effect.No anomalies were found on archive samples checked.No anomalies were found in connection test between sol-m 5ml luer lock syringe w/o needle, ref 180005, lot 19012409 and hurricane needles, ref 2227 lot 190402.Complaint could not be confirmed.There is no evidence of a trend.No immediate corrective action is required and no corrective action is planned.Sol-millennium will continue to monitor the product for reoccurrence.Probability of occurrence was calculated to be 3.8 x 10^-7 and was assessed as low.The severity has been assessed as a serious injury.

Event Description

A doctor (end user) reported that a sol-m 5ml luer lock syringe w/o needle luer lock function did not work correctly.They had screwed the cannula until it came down to the bottom but it continued to screw and it should not do so as it should be locked.A cannula became loose at hydrodissection during cataract surgery when it was inserted into the eye causing internal damage.Per the report, patient was adversely affected by the issue, however it is unknown if medical intervention was required.It is also unknown if surgery was delayed due to the issue.The doctor checked after the event, they could still spin cannula and it was not locked.The end user facility then checked all 5ml syringes that they used and they were all similar in performance (the lock function did not work correctly).The end user facility compared their own syringes and sol-m syringes.Their syringes could not be rotated past the bottom position.

• Brand Name: SOL-M 5ML 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
• Manufacturer Contact: stefanie koenig ; 315 shawnee north dr.; suite 100; suwanee, ga ; 2385673
• MDR Report Key: 10316064
• MDR Text Key: 208207510
• Report Number: 3014312726-2020-00001
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 00818392014815
• UDI-Public: 00818392014815
• Combination Product (y/n): N
• Reporter Country Code: SW
• PMA/PMN Number: K101359
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 07/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/23/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/24/2024
• Device Model Number: 180005
• Device Lot Number: 19012409
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/23/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/08/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other