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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: NERIA¿; NERIA STEEL G27 80/8
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NERIA¿; NERIA STEEL G27 80/8 Back to Search Results
Lot Number 5167726
Medical Device Problem Code Detachment of Device or Device Component (2907)
Health Effect - Clinical Code Tissue Damage (2104)
Type of Reportable Event Serious Injury
Event or Problem Description
(b)(4).Event occurred in (b)(6).The needle remained in the patient's left arm.The patient had six stitches after opening and local anesthetic was used.No further information available.
 
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Brand Name
NERIA¿
Common Device Name
NERIA STEEL G27 80/8
MDR Report Key8334591
Report Number3003442380-2019-00509
Device Sequence Number11343234
Product Code FPA
UDI-Device Identifier05705244001596
UDI-Public05705244001596
Combination Product (Y/N)N
PMA/510(K) Number
K945617
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source distributor
Initial Reporter Occupation Other
Type of Report Initial
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Operator of Device No Information
Device Expiration Date12/01/2021
Device Lot Number5167726
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 11/15/2017
Initial Report FDA Received Date02/13/2019
Patient Sequence Number1
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