MAUDE Adverse Event Report: MEX03 MEXICO-JUAREZ PRESOURCE CARDIAC CATH NORTH (CNSIC)104; GENERAL SURGERY TRAY (KIT)

Model Number	SAN11CNSID
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/01/1980
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The complaint was forwarded to the manufacturing facility and it is currently under investigation.A follow-up report will be filed once investigation is completed.
Event or Problem Description
The customer reported excessive linting of white fibers from the towels from the cardiac catheter pack/ san11cnsid.They could not determine whether it came from the blue towels pwt304-stm or the white towels a8520bn.There was no report of injury.No patient demographics or clinical data was reported.The mdr will be filed for malfunction and potential risk.
Additional Manufacturer Narrative
Mdr follow-up report being filed for excessive linting of white fibers from the blue or towels and the white towels from the cardiac catheter pack/ san11cnsid as investigation results available.A review of the device history record for the blue or towels pwtb04-stm, lot# lot #20181020-23-sh shows that the product was manufactured on 30th oct 2018.Based on the investigation, the device history record review did not indicate any exception that would have led to the reported incident.Evaluation of the device history record shows the average linting data was 0.146g / 10 pieces, an acceptable range.1 piece of sample was returned for visual testing.No obvious lint falling from the substance of the towel detected.The or towel is made of cotton, so lint is born and inevitable.The intended use of or towel is to be used for applying medication to or absorbing small amounts of body fluids from a patient's body surface.Measures to better control and improve linting have been implemented.A suction process was added before products' final folding and operators perform this activity according to standard operation procedure requirements.In the folding process, one cloth bag protects 100 pieces of semi-finished products to avoid linting stuck onto the products during product transfer.Based on the investigation, all linting test data is within the acceptable range.There was no abnormal situation that had happened in production.Therefore, the root cause could not be determined and no further action taken.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.A review of the device history record for the white towel 8520bn, lot #2958bh1 showed that the product was manufactured on october 22nd, 2018.Based on the investigation, the device history record review did not indicate any exception that would have led to the reported incident.A historical review of the towels indicated two reported linting issues during this time period.No sample was provided for evaluation.All operators are certified in their respective operations and the operators or the quality inspector did not identify this condition during their process and continuous inspection.The towel is made with qualified, tested, and approved materials.As a corrective measure, awareness documented training will be reinforced.Based on the limited information available at this time and no product sample provided, the root cause could not be determined.If a sample is provided at a later date, the investigation will be re-opened, and an addendum report will be provided.We will continue monitoring our customer complaints data base for this and any other issues reported of the same nature in this catalog.

• Brand Name: CARDIAC CATH NORTH (CNSIC)104
• 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: 8466579
• Report Number: 1423537-2019-00297
• Device Sequence Number: 19292719
• Product Code: LRO
• UDI-Device Identifier: 10887488973449
• UDI-Public: 10887488973449
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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,Followup
• Report Date (Section B): 06/04/2019

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: SAN11CNSID
• Device Catalogue Number: SAN11CNSID
• Device Lot Number: 15492
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 03/01/2019
• Supplement Date Received by Manufacturer: 03/01/2019
• Initial Report FDA Received Date: 03/29/2019
• Supplement Report FDA Received Date: 06/04/2019
• 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