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U.S. Department of Health and Human Services

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

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SOL-MILLENNIUM MEDICAL INC. SOL-M 1ML LUER LOCK SYRINGE W/O NEEDLE Back to Search Results
Model Number 180001
Device Problems Gas 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.
 
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Brand NameSOL-M 1ML LUER LOCK SYRINGE W/O NEEDLE
Type of DeviceSYRINGE
Manufacturer (Section D)
SOL-MILLENNIUM MEDICAL INC.
315 shawnee north dr.
suite 100
suwanee GA 30024
Manufacturer Contact
stefanie koenig
315 shawnee north dr.
suwanee, GA 30024
4142385673
MDR Report Key11074184
MDR Text Key229816058
Report Number3014312726-2020-00004
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
Reporter Country CodeEZ
PMA/PMN Number
K101359
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,health profession
Reporter Occupation
Type of Report Initial,Followup
Report Date 01/27/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/27/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number180001
Device Lot Number01002002
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/27/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/07/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 12/27/2020 Patient Sequence Number: 1
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