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 Known Impact Or Consequence To Patient (2692)

Event Date 03/30/2018

Event Type  malfunction  

Manufacturer Narrative

Aspen surgical received a report from the end user indicating that a bard-parker blade was discovered with pin holes in the sterile packaging. In this report, it was noted that a lot number was available for evaluation. No sample or photographic evidence was provided. No injury or death was reported. An evaluation of the dhr records for lot number 0159228 was performed. The review determined there were no non-conformance's related to the complaint. The following controls are in-place to mitigate ¿damage package¿ condition at aspen surgical las piedras site: incoming inspection procedures for aluminum foil rolls, including visual inspection for appearance. In-process inspections performed by packaging personnel, including for seal integrity and pouch integrity. ¿high blade¿ sensor at packaging line with ¿high blade¿ sensor challenge at the beginning of a new lot and per shift. Leak test at the beginning of a new lot and every 30 minutes until completion of the lot. Based on this information, the complaint could not be confirmed and no further action is required. Device not available.

Event Description

Aspen surgical received a report from the end user indicating that a bard-parker blade was discovered with pin holes in the packaging. This report was filed in our complaint handling system as complaint #(b)(4).

• 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 ; 6165367508
• MDR Report Key: 7533582
• MDR Text Key: 109228630
• Report Number: 1836161-2018-00046
• 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: health professional,user faci
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/27/2018

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 05/22/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: 371110-150
• Device Lot Number: 0159228
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 04/27/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/09/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial