MAUDE Adverse Event Report: ASPEN SURGICAL PRODUCTS, INC. STERILE NEEDLE COUNTER: 30 COUNT MAGNET WITH CLEAR TOP

Catalog Number NC-3030

Device Problem Unsealed Device Packaging (1444)

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

Event Type  malfunction  

Manufacturer Narrative

Aspen surgical received a report from the distributor indicating that product was found with seal issues.The actual device was not returned for evaluation.The manufacturing lot number was provided for review.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 our distributor indicating that a sterile needle counter package was discovred with sealing issues.No injury or death was reported.This is entered in our system as (b)(4).

• Brand Name: STERILE NEEDLE COUNTER: 30 COUNT MAGNET WITH CLEAR TOP
• Type of Device: NEEDLE COUNTER
• Manufacturer (Section D): ASPEN SURGICAL PRODUCTS, INC.; 6945 southbelt dr se; caledonia MI 49316
• Manufacturer Contact: terry hall ; 6945 southbelt dr se; caledonia, MI 49316 ; 6166987100
• MDR Report Key: 18803502
• MDR Text Key: 337633145
• Report Number: 3002750084-2024-00005
• Device Sequence Number: 1
• Product Code: MMK
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K951736
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 02/28/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/28/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: NC-3030
• Device Lot Number: 2021-10-30
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/31/2024
• 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