MAUDE Adverse Event Report: ASPEN SURGICAL PRODUCTS, CALEDONIA NEEDLE 1/2 CIRCLE TAPER POINT MAYO CATGUT .056X1.969 STERILE; SURGICAL NEEDLE

Model Number 216701

Device Problem Break (1069)

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

Event Date 11/15/2017

Event Type  malfunction  

Event Description

Item number 216701 (needle 1/2 circle taper) broke during use.

• Brand Name: NEEDLE 1/2 CIRCLE TAPER POINT MAYO CATGUT .056X1.969 STERILE
• Type of Device: SURGICAL NEEDLE
• Manufacturer (Section D): ASPEN SURGICAL PRODUCTS, CALEDONIA; 6945 southbelt dr. s.e.; caledonia MI 49316
• Manufacturer (Section G): SAME AS ABOVE
• Manufacturer Contact: jordan hackert ; 6945 southbelt dr. s.e.; caledonia, MI 49316
• MDR Report Key: 7120402
• MDR Text Key: 95772933
• Report Number: 1836161-2017-00129
• Device Sequence Number: 1
• Product Code: GAB
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/14/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 216701
• Device Lot Number: 126178
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/15/2017
• Initial Date FDA Received: 12/15/2017
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1