• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEX03 MEXICO-JUAREZ PRESOURCE CATH PACK (CPBMJ)463 GENERAL SURGERY TRAY (KIT)

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

MEX03 MEXICO-JUAREZ PRESOURCE CATH PACK (CPBMJ)463 GENERAL SURGERY TRAY (KIT) Back to Search Results
Model Number SAN22CPBM3
Device Problem Material Frayed (1262)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 05/13/2019
Event Type  Malfunction  
Manufacturer Narrative

A review of the device history record for the blue non-xray towels (b)(4), lot # 11sa04-sh was manufactured january 2019. Based on the investigation, the device history record review did not indicate any exception that would have led to the reported incident. The supplier checked on the retained sample. (b)(4). No sample was provided for evaluation at this time. The operating room towel is made of cotton, so lint is born and inevitable. The intended use of operating room towel is to be used for applying medication to or absorbing small amounts of body fluids from a patient's body surface. Measures to better control and improve linting have been implemented. A suction process was added before products' final folding and operators perform this activity according to standard operation procedure requirements. In the folding process, one cloth bag protects 100 pieces of semi-finished products to avoid linting stuck onto the products during product transfer. Based on the investigation, all linting test data was within the acceptable range. There was no abnormal situation that had happened in production. Therefore, the root cause could not be determined and no further action taken. The complaint information was shared with the relevant sectors within the manufacturing facility for their awareness and we will continue to monitor for this type of incident.

 
Event Description

The customer reported linting of the blue non-xray towels (b)(4) from the catheterization kit san22cpbm3. No detailed complaint information, patient demographics operating room clinical data was provided after multiple attempts to retrieve from customer. There was no patient injury reported. An mdr is being filed based on potential risk.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameCATH PACK (CPBMJ)463
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 Key8687069
MDR Text Key148446254
Report Number1423537-2019-00323
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
Report Date 06/11/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received06/11/2019
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberSAN22CPBM3
Device Catalogue NumberSAN22CPBM3
Device LOT Number204970
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/13/2019
Was Device Evaluated By Manufacturer? No Answer Provided
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: 06/11/2019 Patient Sequence Number: 1
-
-