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

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.

• Brand Name: RICHARD-ALLAN 3/8 CUTTING NEEDLE
• Type of Device: NEEDLE, SUTURING, DISPOSABLE
• Manufacturer (Section D): ASPEN SURGICAL PRODUCTS, INC.; 6945 southbelt dr. s.e.; caledonia MI 49316
• MDR Report Key: 8054542
• MDR Text Key: 126644873
• Report Number: 8054542
• Device Sequence Number: 1
• Product Code: GAB
• Combination Product (y/n): N
• Number of Events Reported: 1
• 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

1 Patient was Involved in the Event

• Date FDA Received: 11/09/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 209012
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/06/2018
• Date Report to Manufacturer: 11/09/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 21900 DA