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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

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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 10/24/2017
Event Type  malfunction  
Manufacturer Narrative
Root cause is difficult to determine due to no samples being provided for evaluation. However the most possible root cause may be, high blade, foreign matter on rollers, or sharp edges on number die. The following controls are in-place to mitigate ¿damage package¿ condition at (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 ivers lee 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. Quality audits performed by quality inspectors, including for seal integrity and pouch integrity. Machine parts are inspected as part of the weekly machine pm. Device not returned.
 
Event Description
Customer reported that product 371110-150 was discovered to have pin sized holes in the packaging.
 
Manufacturer Narrative
Pending device return.
 
Event Description
Customer reported that product 371110-150 was discovered to have pin sized holes in the packaging.
 
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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
MDR Report Key7080489
MDR Text Key252869480
Report Number1836161-2017-00122
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 distributor
Reporter Occupation
Type of Report Initial,Followup
Report Date 12/19/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/04/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other Health Care Professional
Device Model Number371110-150
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 Received11/06/2017
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

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