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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEX03 MEXICO-JUAREZ PRESOURCE CARDIAC CATH NORTH (CNSIC)104 GENERAL SURGERY TRAY (KIT)

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MEX03 MEXICO-JUAREZ PRESOURCE CARDIAC CATH NORTH (CNSIC)104 GENERAL SURGERY TRAY (KIT) Back to Search Results
Model Number SAN11CNSID
Device Problem Material Frayed (1262)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 01/01/1980
Event Type  Malfunction  
Manufacturer Narrative

The complaint was forwarded to the manufacturing facility and it is currently under investigation. A follow-up report will be filed once investigation is completed.

 
Event Description

The customer reported excessive linting of white fibers from the towels from the cardiac catheter pack/ san11cnsid. They could not determine whether it came from the blue towels pwt304-stm or the white towels a8520bn. There was no report of injury. No patient demographics or clinical data was reported. The mdr will be filed for malfunction and potential risk.

 
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Brand NameCARDIAC CATH NORTH (CNSIC)104
Type of DeviceGENERAL SURGERY TRAY (KIT)
Manufacturer (Section D)
MEX03 MEXICO-JUAREZ PRESOURCE
c. arcadia 1580 , col. terraza
cd.juarez , chihuahua CP 32 599
MX CP 32599
Manufacturer (Section G)
MEX03 MEXICO-JUAREZ PRESOURCE
c. arcadia 1580 , col. terraza
cd.juarez , chihuahua CP 32 599
MX CP 32599
Manufacturer Contact
patricia tucker
3651 birchwood drive
waukegan, IL 60085
8478874151
MDR Report Key8466554
MDR Text Key146370672
Report Number1423537-2019-00300
Device Sequence Number1
Product Code LRO
Combination Product (Y/N)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type HEALTH PROFESSIONAL,USER FACI
Reporter Occupation
Type of Report Initial,Followup
Report Date 06/04/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received03/29/2019
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberSAN11CNSID
Device Catalogue NumberSAN11CNSID
Device LOT Number15492
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/01/2019
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured12/15/2018
Is The Device Single Use? No Answer Provided
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 03/29/2019 Patient Sequence Number: 1
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