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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 15, STERILE

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ASPEN SURGICAL PRODUCTS, CALEDONIA BARD-PARKER CARBON RIB-BACK BLADES SIZE 15, STERILE Back to Search Results
Model Number 371115-150
Device Problems Break (1069); Device Damaged Prior to Use (2284)
Patient Problem No Information (3190)
Event Date 06/29/2017
Event Type  malfunction  
Manufacturer Narrative
The following controls are in-place to mitigate ¿broken blade¿ condition at aspen surgical las piedras site: heat treatment in-process at the beginning and end of each lot are inspected for dimension integrity using a pin gauge, flatness gauge and perforation length gauge, ductility test, and hardness test. Heat treatment quality inspections at the beginning and end of each lot are inspected for dimension integrity using a pin gauge, flatness gauge and perforation length gauge, ductility test, and hardness test. The 100% visual inspection by certified personnel is performed to segregate nonconforming material, including broken blades, prior to assembly and packaging process. Capa (b)(4) was initiated to evaluate current controls in place corrective actions identified were completed and capa closed on 10/26/2015. Capa (b)(4) was also initiated to continue in the monitoring and improvement of current control. Awareness of the complaint received will be discussed.
 
Event Description
The blade was broken within the packaging. The sample was not returned for investigation but the customer was able to provide a picture.
 
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Brand NameBARD-PARKER CARBON RIB-BACK BLADES SIZE 15, STERILE
Type of DeviceBLADE
Manufacturer (Section D)
ASPEN SURGICAL PRODUCTS, CALEDONIA
6945 southbelt dr. s.e.
caledonia MI 49316
Manufacturer (Section G)
SAME AS ABOVE
Manufacturer Contact
megan morrissey
6945 southbelt dr. s.e.
caledonia, MI 49316
MDR Report Key6740523
MDR Text Key81129211
Report Number1836161-2017-00074
Device Sequence Number1
Product Code GES
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor
Reporter Occupation
Type of Report Initial
Report Date 07/25/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/25/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Model Number371115-150
Device Lot NumberUNKNOWN
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 Received06/30/2017
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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