MAUDE Adverse Event Report: ASPEN SURGICAL PRODUCTS, INC. STERILE TIP CLEANER

Model Number TC-100B

Device Problems Device Contaminated During Manufacture or Shipping (2969); Packaging Problem (3007)

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

Event Date 06/05/2015

Event Type  malfunction  

Event Description

Customer rejected 1 piece due to packing failure.Sterile barrier breach.

• Brand Name: STERILE TIP CLEANER
• Type of Device: STERILE TIP CLEANER
• Manufacturer (Section D): ASPEN SURGICAL PRODUCTS, INC.; caledonia MI
• Manufacturer Contact: bradley liske ; 6945 southbelt dr. s.e.; caledonia, MI 49316 ; 6166987100
• MDR Report Key: 4935626
• MDR Text Key: 22460414
• Report Number: 1836161-2015-00069
• Device Sequence Number: 1
• Product Code: KXG
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Not Applicable
• Report Date: 07/17/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/17/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: TC-100B
• Device Lot Number: 69117
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/23/2015
• 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