MAUDE Adverse Event Report: MEX03 MEXICO-JUAREZ PRESOURCE ATHENS CATH PACK (ADARA)132; GENERAL SURGERY TRAY (KIT)

Model Number	SAN21ADARB
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/29/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Based on supplier investigation, the device history record could not be reviewed as a lot number was not provided.No sample was provided for evaluation, only a photo with lint on a glove.The supplier checked on the retained sample.The average linting data was 0.12g/5 pieces and within limits (=0.38g/10 pieces).The operating room 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 is no abnormal situation that has 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 if a sample is returned at a later date, an investigation will be done and a follow up report will be filed.
Event or Problem Description
The customer reported that the blue or towels pwtb04-stm in the catheterization pack san21adarb left a linty residue on the scrub tech¿s gloves and on a wire.The procedure was a cardiac catheterization with percutaneous coronary intervention.No patient demographics were provided, no delay in procedure and no injury occurred.

• Brand Name: ATHENS CATH PACK (ADARA)132
• 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: 8648436
• Report Number: 1423537-2019-00320
• Device Sequence Number: 16252416
• Product Code: LRO
• UDI-Device Identifier: 10887488884516
• UDI-Public: 10887488884516
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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): 05/28/2019

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: SAN21ADARB
• Device Catalogue Number: SAN21ADARB
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/29/2019
• Initial Report FDA Received Date: 05/28/2019
• 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