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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDLINE INDUSTRIES INC. SYRSI101292-SYR W/NDLE, SAFETY, INSLN, 1ML, 29GX0.5"

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MEDLINE INDUSTRIES INC. SYRSI101292-SYR W/NDLE, SAFETY, INSLN, 1ML, 29GX0.5" Back to Search Results
Catalog Number SYRSI101292
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Needle Stick/Puncture (2462)
Event Date 08/17/2019
Event Type  Injury  
Manufacturer Narrative
It was reported by the facility that after the nurse administered insulin to a patient the nurse experienced a needle stick. Per the facility report, after injecting the insulin with her right hand the nurse attempted to use her right index finger to push the safety slide up to activate the feature and she punctured her right index finger with the used syringe. The nurse washed the area with soap and water and went to the local hospital to have a hepatitis panel and hiv test performed per facility protocol. Per the facility report the nurse is feeling fine and there is no evidence of infection. The actual needle used was disposed of and was not returned to the manufacturer for evaluation, according to the reported incident the root cause was determined to be user error. No additional information is available. Due to the reported incident and in an abundance of caution, this medwatch is being filed. If additional relevant information becomes available a supplemental medwatch will be filed.
 
Event Description
It was reported by the facility that after the nurse administered insulin to a patient the nurse experienced a needle stick.
 
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Type of DeviceSYRSI101292-SYR W/NDLE, SAFETY, INSLN, 1ML, 29GX0.5"
Manufacturer (Section D)
MEDLINE INDUSTRIES INC.
three lakes drive
northfield IL 60093
Manufacturer Contact
karen trutsch
three lakes drive
northfield, IL 60093
8476434960
MDR Report Key9413277
MDR Text Key169218608
Report Number1417592-2019-00220
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation
Type of Report Initial
Report Date 12/04/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/04/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberSYRSI101292
Device Lot Number89719060002
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/20/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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: 12/04/2019 Patient Sequence Number: 1
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