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 08/17/2017

Event Type  malfunction  

Event Description

Customer found pin holes in packaging- sterility issue.

Manufacturer Narrative

Aspen surgical received a report indicating that pin holes were discovered in the packaging of a bard-parker blade.No sample was returned evaluation and no manufacturing lot number was provided for review.The following controls are in-place to mitigate ¿damage package¿ condition at aspen surgical (b)(4) 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, no further action is required.Device not returned.

Event Description

Aspen surgical received a report from the end user indicating that pin holes were discovered in packaging of a bard-parker blade.The item was not in use.No injury/death was reported.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: 6908928
• MDR Text Key: 89645602
• Report Number: 1836161-2017-00109
• 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: user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/07/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 371110-150
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/07/2017
• Initial Date FDA Received: 10/02/2017
• Supplement Dates Manufacturer Received: 09/07/2017
• Supplement Dates FDA Received: 03/09/2018
• 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
• Patient Sequence Number: 1