MAUDE Adverse Event Report: ASPEN SURGICAL PRODUCTS, CALEDONIA NEEDLE STRAIGHT CUTTING POINT KEITH ABDOMINAL .034X2.756, STERILE SURGICAL NEEDLE

Model Number 213405

Device Problem Material Protrusion/Extrusion (2979)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/04/2021

Event Type  malfunction  

Event Description

Aspen surgical received a report from the end user indicating that a needle was poking through the packaging of the product. The item was not in use. The report was filed in our complaint handling system as number (b)(4).

Manufacturer Narrative

Aspen surgical received a report from the end user indicating that a needle poked through the packaging. A sample and photographic evidence was available for evaluation. A manufacturing lot number was provided for review. A review of the device history record was completed. No non-conformance's were noted relating to the reported issue. After review of the sample, it was observed that the packaging of the product was bent causing the needle to protrude through the pouch of the product. The seals of pouch was intact and the product was not damaged. Therefore the cause of the issue with the product protruding through the pouch is unable to be determined. Based on this information, no further action is required.

• Brand Name: NEEDLE STRAIGHT CUTTING POINT KEITH ABDOMINAL .034X2.756, 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: 12916269
• MDR Text Key: 283676340
• Report Number: 1836161-2021-00044
• 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

• Type of Report: Initial
• Report Date: 11/04/2021

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 12/02/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: 213405
• Device Lot Number: 168107
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/04/2021
• 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