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 Patient Involvement (2645)

Event Date 05/18/2018

Event Type  malfunction  

Manufacturer Narrative

Aspen surgical received a report from the end user indicating that bard-parker blades were discovered with pin holes in the sterile packaging.In this report, it was noted that the following lot numbers were discovered with the issue: 0153969, 0125104, 0111571, 0133203, and 0105854.No samples were provided.Photographic evidence was available for review.No injury or death was reported.An evaluation of the dhr records for the lot numbers listed above were performed.The review determined there were no non-conformance's related to the complaint for each lot number.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.Although no samples were provided, the most probable root cause may be from foreign matter on the machine rollers during the packaging process.If a sample is determined to be returned and if any additional relevant information is identified following completion of the sample review, the additional relevant information will be submitted in a supplemental report.Based on this information, no further action is required.

Event Description

Aspen surgical received a report from the end user indicating that bard-parker blades were discovered with pin holes in the packaging.This report was filed in our complaint handling system for multiple lot numbers.The complaint references for these lot numbers are as follows: (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: 7588461
• MDR Text Key: 111099910
• Report Number: 1836161-2018-00052
• 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: 05/18/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/11/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 371110-150
• Device Lot Number: SEE ABOVE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/18/2018
• 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