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

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.

• Brand Name: CARDIAC CATH PACK (CBCHQ)840
• Type of Device: GENERAL 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 Key: 9847318
• MDR Text Key: 201712770
• Report Number: 1423537-2020-00437
• Device Sequence Number: 1
• Product Code: LRO
• UDI-Device Identifier: 10888439004267
• UDI-Public: 10888439004267
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• 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 Received: 03/18/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/01/2023
• Device Model Number: SAN11CBCHR
• Device Catalogue Number: SAN11CBCHR
• Device Lot Number: 369759
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/27/2020
• Date Device Manufactured: 01/03/2020
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 73 YR
• Patient Weight: 73