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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYRINGE 1ML LS SP120
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SYRINGE 1ML LS SP120 Back to Search Results
Catalog Number 303172
Device Problem Fluid/Blood Leak (1250)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/28/2021
Event Type  malfunction  
Manufacturer Narrative
A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
 
Event Description
It was reported that at least one syringe 1ml ls sp120 experienced leakage.The following information was provided by the initial reporter: numerous syringes had air bubbles that appeared to be in the internal surface of the syringe.Often the low dead space needles did not securely connect to syringes and leaked.This caused a shortfall/wastage of vaccine.5 in lieu of 6 doses.Has been happening since first lot of 302100 arrived.Hundreds of syringes affected.30-40% of stock - think they are all from the same lot.Low dose needle being used to connect to syringes for vaccine administration.
 
Event Description
It was reported that at least one syringe 1ml ls sp120 experienced leakage.The following information was provided by the initial reporter: numerous syringes had air bubbles that appeared to be in the internal surface of the syringe.Often the low dead space needles did not securely connect to syringes and leaked.This caused a shortfall/wastage of vaccine.5 in lieu of 6 doses.Has been happening since first lot of 302100 arrived.Hundreds of syringes affected.30-40% of stock - think they are all from the same lot.Low dose needle being used to connect to syringes for vaccine administration.
 
Manufacturer Narrative
The following fields were updated due to additional information: d10: device available for eval yes.D10: returned to manufacturer on: 2021-08-13 investigation summary: samples were received for investigation, samples were visually inspected finding bubbles in the lower part of the tip and in the middle of the barrel.No defects observed on the tip of the syringe.A device history review was performed for lot 2012054, no deviations or non-conformances were identified during the manufacturing process that could have contributed to the reported issue.Possible root cause for air bubbles, may occur during molding process due to air entrance in the mold.This is a cosmetic defect, and the product functionality is not affected.Since manufacturing record established that all production and quality processes were carried out normally, we cannot confirm the root cause for syringe connectivity issue.Product undergoes inspections throughout the manufacturing process to ensure the quality and functionality of the device, including verification all critical dimensions are within specification and there is no damage on the product.Manufacturing personnel have been notified of this incident to increase awareness of this matter.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored monthly.Our business team regularly reviews the collected data for identification of emerging trends.
 
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Brand Name
SYRINGE 1ML LS SP120
Type of Device
SYRINGE
MDR Report Key12414193
MDR Text Key282774810
Report Number3003152976-2021-00540
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
PMA/PMN Number
NA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,other,user facility
Type of Report Initial,Followup
Report Date 10/05/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/02/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number303172
Device Lot Number2012054
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/13/2021
Date Manufacturer Received10/05/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/11/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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