MAUDE Adverse Event Report: ASPEN SURGICAL PRODUCTS, INC. RICHARD-ALLAN NEEDLES, 1/2 CUTTING; NEEDLE, SUTURING, DISPOSABLE

Model Number 209110

Device Problem Break (1069)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/11/2020

Event Type  malfunction  

Event Description

Free needle was being used and broke into two pieces.Both pieces were accounted for and take off the field.

• Brand Name: RICHARD-ALLAN NEEDLES, 1/2 CUTTING
• Type of Device: NEEDLE, SUTURING, DISPOSABLE
• Manufacturer (Section D): ASPEN SURGICAL PRODUCTS, INC.; 6945 southbelt dr. s.e.; caledonia MI 49316
• MDR Report Key: 10122755
• MDR Text Key: 194142659
• Report Number: 10122755
• 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: 06/01/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/05/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 209110
• Device Lot Number: 202246
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/01/2020
• Event Location: Hospital
• Date Report to Manufacturer: 06/05/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 25915 DA