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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ASPEN SURGICAL PRODUCTS, INC. RICHARD-ALLAN 3/8 CUTTING NEEDLE NEEDLE, SUTURING, DISPOSABLE

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ASPEN SURGICAL PRODUCTS, INC. RICHARD-ALLAN 3/8 CUTTING NEEDLE NEEDLE, SUTURING, DISPOSABLE Back to Search Results
Catalog Number 209012
Device Problems Break (1069); Detachment of Device or Device Component (2907)
Patient Problem No Code Available (3191)
Event Date 10/19/2018
Event Type  malfunction  
Event Description
Eye of free needle broke off while inserting chest tube suture, wound explored by surgeon, unable to locate eye of free needle.
 
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Brand NameRICHARD-ALLAN 3/8 CUTTING NEEDLE
Type of DeviceNEEDLE, SUTURING, DISPOSABLE
Manufacturer (Section D)
ASPEN SURGICAL PRODUCTS, INC.
6945 southbelt dr. s.e.
caledonia MI 49316
MDR Report Key8054542
MDR Text Key126644873
Report Number8054542
Device Sequence Number1
Product Code GAB
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Risk Manager
Type of Report Initial
Report Date 11/06/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/09/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number209012
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA11/06/2018
Event Location No Information
Date Report to Manufacturer11/09/2018
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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