MAUDE Adverse Event Report: ASPEN SURGICAL PRODUCTS, CALEDONIA NEEDLE 3/8 CIRCLE REVERSE CUTTING, .037X1.535, STERILE; SURGICAL NEEDLE

Model Number 209012

Device Problems Material Fragmentation (1261); Device Or Device Fragments Location Unknown (2590)

Patient Problem No Information (3190)

Event Date 07/31/2017

Event Type  Injury  

Event Description

During surgical procedure to secure chest tube, it was noted that the very tip of the needle (approximately 2 mm) had broken off.The tip could not be found.

Event Description

During surgical procedure to secure chest tube, it was noted that the very tip of the needle (approximately 2mm) had broken off.The tip could not be found.

• Brand Name: NEEDLE 3/8 CIRCLE REVERSE CUTTING, .037X1.535, 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: 6883198
• MDR Text Key: 87170542
• Report Number: 1836161-2017-00097
• 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: Health Professional
• Type of Report: Initial,Followup
• Report Date: 02/05/2018

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
• Device Operator: Physician
• Device Model Number: 209012
• Device Lot Number: 124905
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/21/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/24/2017
• Initial Date FDA Received: 09/21/2017
• Supplement Dates Manufacturer Received: 08/24/2017
• Supplement Dates FDA Received: 02/05/2018
• Was Device Evaluated by Manufacturer?: Yes
• 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
• Patient Outcome(s): Other
• Patient Age: 76 YR