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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEX03 MEXICO-JUAREZ PRESOURCE CARDIAC CATH PACK SSP (CCSTH)626 GENERAL SURGERY TRAY (KIT)

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MEX03 MEXICO-JUAREZ PRESOURCE CARDIAC CATH PACK SSP (CCSTH)626 GENERAL SURGERY TRAY (KIT) Back to Search Results
Model Number SCV5CCCSTI
Device Problem Material Frayed (1262)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 09/25/2019
Event Type  Malfunction  
Manufacturer Narrative

Based on supplier investigation, the device history record, lot# 20190717-23-sh was manufactured on 25th jul 2019. No exception was recorded in the device history record that could lead to the reported incident. The average linting data is 0. 205g / 10 pieces. No sample was returned to the supplier at the time of the investigation, only a photo with little blue lint on the white gauze was provided. According to the manufacturer, the or towel is made of cotton, so lint is born and inevitable. The intended use of or towel is used for applying medication or absorbing small amounts of body fluids from a patient's body surface. The manufacturer will continue to work with cardinal health to better control the linting and they have implemented several measures to improve it: the suction process was added before products' final folding and operators do it according to standard operation procedure requirements. Linting test method and acceptable criteria was stipulated to see the suction results (=0. 38g/10 pieces). In the folding process, the manufacturer used one cloth bag protect 100 pieces semi-finished products to avoid linting stuck onto the products during products' transfer. From the investigation, no abnormal situation happened in production and all linting test data were within the acceptable range. Therefore, the root cause could not be determined. 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 that the or towels/ pwtb04-stm from the cardiac catheter pack/ scv5cccsti were linting during a coronary angiogram. The towels were used to absorb blood and fluid on the patient's drape. The customer stated that there was no patient harm. No patient demographics were provided. Although there was no injury, cardinal health is proactively filing a medwatch.

 
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Brand NameCARDIAC CATH PACK SSP (CCSTH)626
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 Key9211056
MDR Text Key208401251
Report Number1423537-2019-00363
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 COMPANY REPRESENTATIVE,CONSUM
Reporter Occupation
Type of Report Initial
Report Date 10/18/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received10/18/2019
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberSCV5CCCSTI
Device Catalogue NumberSCV5CCCSTI
Device LOT Number299570
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/26/2019
Was Device Evaluated By Manufacturer? No Answer Provided
Date Device Manufactured08/27/2019
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: 10/18/2019 Patient Sequence Number: 1
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