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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES CNO11, GELPOINT PATH 5.5CM FER

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APPLIED MEDICAL RESOURCES CNO11, GELPOINT PATH 5.5CM FER Back to Search Results
Model Number 15
Device Problems Break (1069); Material Fragmentation (1261)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 02/25/2015
Event Type  malfunction  
Manufacturer Narrative
The event unit was returned to applied medical for evaluation. Upon inspection, engineering confirmed the customer experience that one sleeve had separated from its septum. A review of the manufacturing records for the lot number provided revealed that the product passed all quality and manufacturing inspections. The root cause of the separated septum is the swab being pushed through. It is likely the swab was not lubricated and the highly textured surface of the material would cause enough friction to push the septum out of the sleeve. If an aggressive angle was used to insert and remove the swab this could have contributed to the septum separation. The instructions for use caution ""to minimize eversion of the sleeves seal, instruments with high textured surfaces should be coated with a sterile lubricant. " in addition, "all instruments should be centered axially when inserted through the sleeves seal for easier insertion. " this report is being filed as a result of a re-review of applied medical complaints received between june 1, 2014 and may 31, 2016. This retrospective review was associated with a quality management system (qms) compliance action plan developed and presented to fda to address an april 10, 2015 warning letter. Applied medical has revised its mdr reporting criteria to be more conservative and has improved complaint handling and mdr reporting processes. The reviews ensured that recent reportable events were appropriately identified and reported to the designated regulatory authority(ies). This report, which represents the initial and final reports combined, is being submitted based on the findings of that retrospective review. In accordance to 21 cfr 803. 56, if additional information is obtained which was not known or was not available when this report was submitted, then a supplemental report will be submitted to the fda.
 
Event Description
Tamis- "surgeon put a little swap through. Swap pulled of the seal. It was torn off. Swap was stuck on the seal. " patient status - "patient is ok".
 
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Brand NameCNO11, GELPOINT PATH 5.5CM
Type of DeviceFER
Manufacturer (Section D)
APPLIED MEDICAL RESOURCES
22872 avenida empresa
rancho santa margarita CA 92688
Manufacturer Contact
22872 avenida empresa
rancho santa margarita, CA 92688
9497138233
MDR Report Key6385922
MDR Text Key69328711
Report Number2027111-2017-01490
Device Sequence Number1
Product Code FER
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial
Report Date 03/07/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/07/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date04/29/2017
Device Model Number15
Device Catalogue Number15
Device Lot Number1221910
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/19/2015
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/25/2015
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/01/2014
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 03/07/2017 Patient Sequence Number: 1
Treatment
5MM TROKAR COVIDIEN, OCTUPORT, AIRSEAL TROKAR 12MM
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