MAUDE Adverse Event Report: MEX03 MEXICO-JUAREZ PRESOURCE CATH LAB ACCESSORY TRAY (CLSMJ)673; GENERAL SURGERY TRAY (KIT)

Model Number	SAN5BCLSMK
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/24/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A review of the device history record for the blue non-xray cotton towels 101625, lot#11r1o2-sh did not indicate any exception that would have led to the reported incident.The supplier checked on the retained sample.The average linting data was 0.11g / 10 pieces and within limits (=0.38g/10 pieces).No sample was provided for evaluation at this time.Based on the investigation, all linting test data was 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.
Event or Problem Description
The customer reported threads coming out of or off of the blue non-xray cotton towels 101625 from the cath lab accessory tray/ (b)(4).The procedure performed was an angiogram.The cotton towels were used as a mat to lay the instruments on where the instruments would slip through the weave of the towel catching threads.The staff was able to catch any loose threads before use on the patient.The instrument was then wiped off using a wet 4x4 gauze sponge causing minimal delay.There was no patient injury.No patient demographics were provided.

• Brand Name: CATH LAB ACCESSORY TRAY (CLSMJ)673
• 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: 8818042
• Report Number: 1423537-2019-00335
• Device Sequence Number: 3147005
• Product Code: LRO
• UDI-Device Identifier: 10888439230321
• UDI-Public: 10888439230321
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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): 07/23/2019

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: SAN5BCLSMK
• Device Catalogue Number: SAN5BCLSMK
• Device Lot Number: 145946
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/24/2019
• Initial Report FDA Received Date: 07/23/2019
• 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