MAUDE Adverse Event Report: ASPEN SURGICAL PRODUCTS, CALEDONIA BARD-PARKER CARBON RIB-BACK BLADES SIZE 10, STERILE BARD-PARKER BLADE

Model Number 371110-150

Device Problem Tear, Rip or Hole in Device Packaging (2385)

Patient Problem No Information (3190)

Event Date 10/24/2017

Event Type  malfunction  

Manufacturer Narrative

The following controls are in-place to mitigate ¿damage package¿ condition at aspen surgical (b)(4) site: 1. Incoming inspection procedures for aluminum foil rolls, including visual inspection for appearance. 2. In-process inspections performed by packaging personnel, including for seal integrity and pouch integrity. 3. ¿high blade¿ sensor at (b)(4) packaging line with ¿high blade¿ sensor challenge at the beginning of a new lot and per shift. 4. Leak test at the beginning of a new lot and every 30 minutes until completion of the lot. 5. Quality audits performed by quality inspectors, including for seal integrity and pouch integrity. 6. Machine parts are inspected as part of the weekly machine pm. Device not available.

Event Description

Customer reported that product 371110-150 was discovered to have pin sized holes in the packaging.

• Brand Name: BARD-PARKER CARBON RIB-BACK BLADES SIZE 10, STERILE
• Type of Device: BARD-PARKER BLADE
• 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: 7101116
• Report Number: 1836161-2017-00124
• Device Sequence Number: 1
• Product Code: GES
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor

Reporter Occupation

• Type of Report: Initial
• Report Date: 12/08/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/08/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other Health Care Professional
• Device Model Number: 371110-150
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 11/08/2017
• 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