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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEX03 MEXICO-JUAREZ PRESOURCE CARDIAC CATH PACK (CBCHQ)840 GENERAL SURGERY TRAY (KIT)

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MEX03 MEXICO-JUAREZ PRESOURCE CARDIAC CATH PACK (CBCHQ)840 GENERAL SURGERY TRAY (KIT) Back to Search Results
Model Number SAN11CBCHR
Device Problem Material Integrity Problem (2978)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 02/27/2020
Event Type  Malfunction  
Manufacturer Narrative

From the device history record, lot number 20190816-23-sh was manufactured on august 16, 2018. No exception was recorded in the device history record that could lead to the reported incident. No sample was available for evaluation. The average linting data is 0. 202g / 10 pieces. The linting test data were within the acceptable range, therefore, the root cause could not be determined from this investigation. According to our supplier, or towels are made of cotton, so lint is born and inevitable. We are continuously working to better control the linting and have implemented the following: suctions machines have been installed in grey cloth rolling process, dyeing process and cutting process. The suction process was added before product's final folding, and workers do it according to standard operation procedure requirement. Linting test method and acceptable criteria was stipulated to see the suction results. (=0. 38g/10 pieces). In the folding process, the supplier used one cloth pad under 100 pieces semi-finished products to avoid linting stuck onto the products during product's transfer. The complaint information was informed to the relevant sectors for their awareness. There is no action taken at this time, however, will continue to monitor the trend of this type of incident.

 
Event Description

Based on information received from the customer, reportedly some of the towels have a noticeable abundance of lint. Customer reported no injury to patient.

 
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Brand NameCARDIAC CATH PACK (CBCHQ)840
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 Key9847318
MDR Text Key201712770
Report Number1423537-2020-00437
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 USER FACILITY
Reporter Occupation
Type of Report Initial
Report Date 03/18/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received03/18/2020
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberSAN11CBCHR
Device Catalogue NumberSAN11CBCHR
Device LOT Number369759
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/27/2020
Was Device Evaluated By Manufacturer? No Answer Provided
Date Device Manufactured01/03/2020
Is The Device Single Use? No Answer Provided
Is this a Reprocessed and Reused Single-Use Device?
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 03/18/2020 Patient Sequence Number: 1
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