MAUDE Adverse Event Report: MEX03 MEXICO-JUAREZ PRESOURCE ANGIO PACK (ANEJC)644; GENERAL SURGERY TRAY (KIT)

Model Number	SAN43ANEJD
Health Effect - Clinical Code	Hemolysis (1886)
Date of Event	01/16/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Based on supplier investigation, device history record could not be reviewed as lot number was not provided.Supplier reviewed the device history record for the last two years and no abnormal findings were found.No sample was returned for investigation, only photos were provided.There was blue lint seen in the catheter.According to supplier, or towel is made of cotton, so cotton fiber is born.The operating room towel is a disposable product, and its intended use is as follows: a device intended for medical purposes that is made from cotton or synthetic fiber in the shape of a ball or a pad and that is used for applying medication to, or absorbing small amounts of body fluids from, a patient's body surface.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, there is no abnormal situation that has 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 or Problem Description
The customer reported linting from the blue surgical towels pwtb04-stm from the angiography pack san43anejd during a cardiac left heart angiogram.Patient ended up with a severe hemolysis episode.The towels were used to absorb fluids in the fields and towels were saturated with saline to help in the assistance of holding wires, catheters, and other tools in place.Customer reported there was no delay as towels were removed when linting was noticed.There was no other type of patient injury reported.Mdr being filed for risk to patient.

• Brand Name: ANGIO PACK (ANEJC)644
• Common Device Name: 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
• MDR Report Key: 9741817
• Report Number: 1423537-2020-00424
• Device Sequence Number: 11213148
• Product Code: LRO
• UDI-Device Identifier: 10888439280197
• UDI-Public: 10888439280197
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: SAN43ANEJD
• Device Catalogue Number: SAN43ANEJD
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/23/2020
• Initial Report FDA Received Date: 02/21/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 47 YR
• Patient Weight: 109