MAUDE Adverse Event Report: CONVERTORS DE MEXICO, S.A. DE C.V. FAYETTE EYE PACK (EPPMF)132; GENERAL SURGERY TRAY (KIT)

Model Number	SEY21EPPMG
Health Effect - Clinical Code	No Information (3190)
Date of Event	01/18/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The customer stated that the non-xray gauze (b)(4) was disintegrating when pulling away each piece from another during the eye case.This caused 1/4 inch white threads to go everywhere including the back table, instrumentation, patient's face and eye.The fibers were removed by flushing the patient's eye.We were unable to conduct a device history record review for the given product quality report, as the lot provided is invalid.According to our supplier, (b)(4), gauze swabs are made of absorbent gauze after cutting and folding.For lint, their inspection method and acceptable criteria are as below: a.Hold the folded side of the gauze, shaking the gauze around and lint falling should be no more than 10 units.The supplier (b)(4)random sampled 5 retained lot samples and tested them following the above method.They found that the products are within their acceptable criteria.As a sample was not available for further investigation, the root cause could not be determined.Action plan- feedback and monitor.The complaint information was sent to the relevant sectors for their awareness.There is no additional action taken at this time, but (b)(4) will continue to monitor the trend of this type of incident.If a sample is returned at a later date, an addendum to this investigation will be performed.
Event or Problem Description
The customer stated that the non-xray gauze (b)(4) was disintegrating when pulling away each piece from another during the eye case.This caused 1/4 inch white threads to go everywhere including the back table, instrumentation, patient's face and eye.The fibers were removed by flushing the patient's eye.

• Brand Name: FAYETTE EYE PACK (EPPMF)132
• Common Device Name: GENERAL SURGERY TRAY (KIT)
• Manufacturer (Section D): CONVERTORS DE MEXICO, S.A. DE C.V.; c. arcadia 1580 , col. terraza; cd.juarez , chihuahua CP 32 599; MX CP 32599
• MDR Report Key: 7278161
• Report Number: 1423537-2018-00158
• Device Sequence Number: 19334531
• Product Code: LRO
• UDI-Device Identifier: 10887488637686
• UDI-Public: 10887488637686
• 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
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 02/16/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Nurse
• Device Model Number: SEY21EPPMG
• Device Catalogue Number: SEY21EPPMG
• Device Lot Number: 780874
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/18/2018
• Initial Report FDA Received Date: 02/16/2018
• 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