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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYRINGE 1.0ML 31G 6MM S/C U-100 RELION; PISTON SYRINGE
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SYRINGE 1.0ML 31G 6MM S/C U-100 RELION; PISTON SYRINGE Back to Search Results
Model Number 328519
Device Problems Defective Device (2588); Material Deformation (2976)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 09/09/2021
Event Type  malfunction  
Manufacturer Narrative
Date of event: unknown.Medical device expiration date: na.A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.
 
Event Description
It was reported that syringe 1.0ml 31g 6mm s/c u-100 relion was damaged and had molding defects.This occurred on 7 occasions.The following information was provided by the initial reporter: it was reported customer found 7 barrels that are cracked and have bubble looking bumps in the barrels too.
 
Manufacturer Narrative
The following fields were updated due to additional information: d10: device available for eval yes.D10: returned to manufacturer on: 2021-10-04.H6: investigation summary customer returned (25) loose 31gx6mm, 1ml insulin syringes.The consumer reported found 7 barrels that are cracked and have bubble looking bumps in the barrels too.All 25 returned syringes were examined, and it was observed that 20 out of the 25 syringes exhibited small gouges on the surface of the barrel between the 20- and 30- unit scale markings.All 25 syringes were then tested for flow, and it was observed that all 25 syringes were able to draw and expel properly.No defects inside the barrels were observed.A review of the device history record was completed for batch# 0217457.All inspections were performed per the applicable operations qc specifications.There was one (1) notification noted for damaged barrel.Bd was able to duplicate or confirm the customer¿s indicated failure.H3 other text : see h10.
 
Event Description
It was reported that syringe 1.0ml 31g 6mm s/c u-100 relion was damaged and had molding defects.This occurred on 7 occasions.The following information was provided by the initial reporter: it was reported customer found 7 barrels that are cracked and have bubble looking bumps in the barrels too.
 
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Brand Name
SYRINGE 1.0ML 31G 6MM S/C U-100 RELION
Type of Device
PISTON SYRINGE
MDR Report Key12594653
MDR Text Key275425943
Report Number1920898-2021-01049
Device Sequence Number1
Product Code FMF
UDI-Device Identifier00681131138345
UDI-Public00681131138345
Combination Product (y/n)N
PMA/PMN Number
K170386
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,other
Type of Report Initial,Followup
Report Date 10/14/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Model Number328519
Device Catalogue Number328519
Device Lot Number0217457
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/04/2021
Initial Date Manufacturer Received 09/09/2021
Initial Date FDA Received10/07/2021
Supplement Dates Manufacturer Received10/08/2021
Supplement Dates FDA Received11/03/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/04/2020
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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