• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

ASPEN SURGICAL PRODUCTS, CALEDONIA BARD-PARKER CARBON RIB-BACK BLADES SIZE 10, STERILE BARD-PARKER BLADE Back to Search Results
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).
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameBARD-PARKER CARBON RIB-BACK BLADES SIZE 10, STERILE
Type of DeviceBARD-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 Key7588461
MDR Text Key111099910
Report Number1836161-2018-00052
Device Sequence Number1
Product Code GES
Combination Product (y/n)N
Reporter Country CodeCA
Number of Events Reported1
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
0 Patients were Involved in the Event:
Date FDA Received06/11/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number371110-150
Device Lot NumberSEE ABOVE
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 Received05/18/2018
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

-
-