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

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.

• Brand Name: CARDIAC CATH PACK SSP (CCSTH)626
• 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: 9211056
• MDR Text Key: 208401251
• Report Number: 1423537-2019-00363
• Device Sequence Number: 1
• Product Code: LRO
• UDI-Device Identifier: 10887488809700
• UDI-Public: 10887488809700
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Reporter Occupation: Other
• 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 Received: 10/18/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: SCV5CCCSTI
• Device Catalogue Number: SCV5CCCSTI
• Device Lot Number: 299570
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/26/2019
• Date Device Manufactured: 08/27/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other