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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEX03 MEXICO-JUAREZ PRESOURCE IR NEURO PACK 629 NEUROLOGICAL TRAY

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MEX03 MEXICO-JUAREZ PRESOURCE IR NEURO PACK 629 NEUROLOGICAL TRAY Back to Search Results
Model Number SAN44IRUTA
Device Problem Material Fragmentation (1261)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 04/29/2020
Event Type  Malfunction  
Manufacturer Narrative

From the device history record, lot# 20190920-23-sh was manufactured on 26th sep 2019. No exception was recorded in the device history record that could lead to the reported incident. The average linting data is 0. 184g / 10 pieces. A sample was not available at the time of the investigation, only photo of blue lint was provided. According to supplier, or towel is made of cotton, so cotton fiber is born. Supplier is continuously working with cardinal health to better control the linting and have implemented several measures to improve it: 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, supplier used one cloth pad under 100 pieces semi-finished products to avoid linting stuck onto the products during product's transfer. From the investigation, no abnormal situation happened in production. Therefore, the root cause could not be determined. The complaint information was informed to the relevant sectors for their awareness. There is no action taken at this time, but supplier will continue to monitor the trend of this type of incident.

 
Event Description

Customer reported that the blue, sterile, cotton or towels pwtb04-stm, from the ir neuro pack san44iruta are shedding fibers onto various wires and catheters during a intracranial embolization. The towels were used for fluid absorption outside the drape. There was no injury or delay. Cardinal health is filing a report for malfunction.

 
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Brand NameIR NEURO PACK 629
Type of DeviceNEUROLOGICAL TRAY
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 Key10063105
MDR Text Key208344848
Report Number1423537-2020-00460
Device Sequence Number1
Product Code OJG
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 05/15/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received05/15/2020
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator NO INFORMATION
Device MODEL NumberSAN44IRUTA
Device Catalogue NumberSAN44IRUTA
Device LOT Number339307
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/30/2020
Was Device Evaluated By Manufacturer? No Answer Provided
Date Device Manufactured10/30/2019
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: 05/15/2020 Patient Sequence Number: 1
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