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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 Known Impact Or Consequence To Patient (2692)
Event Date 08/17/2017
Event Type  malfunction  
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).
 
Event Description
Customer found pin holes in packaging- sterility issue.
 
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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
6165367508
MDR Report Key6908928
MDR Text Key253601888
Report Number1836161-2017-00109
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 user facility
Reporter Occupation
Type of Report Initial,Followup
Report Date 09/07/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/02/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
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 Received09/07/2017
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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