MAUDE Adverse Event Report: ASPEN SURGICAL PRODUCTS, CALEDONIA NEEDLE STRAIGHT CUTTING POINT KEITH ABDOMINAL .040X3.465, STERILE; SURGICAL NEEDLE

Model Number 213402

Device Problems Tear, Rip or Hole in Device Packaging (2385); Material Protrusion/Extrusion (2979)

Patient Problem Needle Stick/Puncture (2462)

Event Date 01/21/2022

Event Type  malfunction  

Manufacturer Narrative

No further information is available on the product at this time.The product was not returned for investigation.However if any additional relevant information is identified, the additional relevant information will be submitted in a supplemental report.

Event Description

Aspen surgical received a report from the end user indicating that a user was poked by needle protruding through the packaging.No intervention was required.The protruding needle is a sterility issue as the packaging was compromised.The issue was filed under our complaint handling system under number c-(b)(4).

• Brand Name: NEEDLE STRAIGHT CUTTING POINT KEITH ABDOMINAL .040X3.465, 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 ; 6165367508
• MDR Report Key: 13549362
• MDR Text Key: 290680690
• Report Number: 1836161-2022-00005
• 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 Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/21/2022

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: 213402
• Device Lot Number: 269958
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/21/2022
• Initial Date FDA Received: 02/17/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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