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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEX03 MEXICO-JUAREZ PRESOURCE PACEMAKER PACK (PCCAL)665 GENERAL SURGERY TRAY (KIT)

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MEX03 MEXICO-JUAREZ PRESOURCE PACEMAKER PACK (PCCAL)665 GENERAL SURGERY TRAY (KIT) Back to Search Results
Model Number SCV13PCCAA
Device Problems Material Fragmentation (1261); Material Frayed (1262); Device Damaged Prior to Use (2284)
Patient Problem No Patient Involvement (2645)
Event Date 12/11/2019
Event Type  Malfunction  
Manufacturer Narrative

Based on supplier investigation, the device history record review did not indicate any exception that could lead to the reported incident. No sample returned at the time of the investigation, only photo of the defect sample was provided. The edge of this product was not completely folded well. From the investigation, the supplier determined the root cause as the gauze roll was not properly set up to folding machine, the position of gauze roll will be uneven, it will caused one side of the gauze product is not completely folded well. The operator failed to sort out the defective sample. The complaint information was sent to the relevant sectors for their awareness. There is no further action taken at this time, but the supplier will continue to monitor the trend of this type of incident.

 
Event Description

Customer reported the sponge edges appear crumbly and are frayed. Reportedly, fragments of the sponge were noted within the pack when opened on the table before the procedure.

 
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Brand NamePACEMAKER PACK (PCCAL)665
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 dr
waukegan, IL 60085
8478874151
MDR Report Key9572354
MDR Text Key198600198
Report Number1423537-2020-00391
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,HEALTH
Reporter Occupation
Type of Report Initial
Report Date 01/09/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received01/09/2020
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberSCV13PCCAA
Device Catalogue NumberSCV13PCCAA
Device LOT Number241830
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/11/2019
Was Device Evaluated By Manufacturer? No
Date Device Manufactured05/20/2019
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device?
Type of Device Usage

Patient TREATMENT DATA
Date Received: 01/09/2020 Patient Sequence Number: 1
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