MAUDE Adverse Event Report: CONVERTORS DE MEXICO, S.A. DE C.V. CATARACT PACK (CTPHK)269; GENERAL SURGERY TRAY (KIT)

Model Number SEY54CTPHL

Device Problem Material Disintegration (1177)

Patient Problem Foreign Body In Patient (2687)

Event Date 12/08/2017

Event Type  Injury  

Manufacturer Narrative

The customer stated that a blue fiber reportedly from the cataract pack/sey54ctphl was found in the patient¿s eye after cataract surgery.The component source was unknown, but the customer felt the linting was from the gown 9545nc.A drape 9358na and back table cover 8145w were also in this kit.All three blue fibrous items in kit were investigated.The patient did go back to surgery to have the fiber removed.There was no injury to the patient and the patient was doing well.A sample was not received for any of the components that were investigated for this report.Without a sample provided we cannot determine a root cause at this time.If a sample is returned at a later date, the investigation will be reopened and an addendum report will be provided.There is no additional action taken at this time, but will continue to monitor the trend of this type of incident.From the device history record, back table cover 8145w lot number 2547bh2 was produced using the following part number 14105w with raw materials: reinforcement part number 1115523 traceability (b)(4), plastic film part number 28100-2 traceability (b)(4), produced during second shift.Drape 9358na lot number 2727cc1 using the raw material (sms) (b)(4) with the following traceability (b)(4) during first shift.Gown 9545ncc lot# 2207aq was manufactured on 28th jul to 04th aug 2017.No exception was recorded in the device history record that could lead to the reported incident.After evaluation of back table cover 8145w and drape 9358na, the operators or the quality inspectors did not identify this condition during their process and continuous inspections.Awareness documented training was provided to the employees involved in the processes of these products in order to be alert about this kind of issues.We will continue monitoring our customer¿s complaint data base for this and any other issues reported of the same nature in this catalog.Finished good audits are being performed randomly in order to detect potential issues of the same nature.Our products are evaluated according to the requirements of specification and qsr's applicable, taking into account the release and cleaning of the area.After review of the finished goods inspection record, we didn¿t find the experiencing fibers in the gown 9545nc.According to the present investigation, there is no such similar phenomenom happening on the surface of the gown.The type of fiber is unknown and it is unknown if the fibers are from a gown and which portion of gown or the pack.So we cannot determine a root cause at this time.No corrective action at present for the gown, but we will continue to follow and monitor this feedback.

Event Description

The customer stated that a blue fiber reportedly from the cataract pack/sey54ctphl was found in the patient¿s eye after cataract surgery.The component source was unknown but the customer felt the linting was from the gown.A drape and back table cover were also in this kit, although the customer had indicated they believed the fibers were coming from the gowns.The patient did go back to surgery to have the fiber removed.There was no injury to the patient and the patient was doing well.

Manufacturer Narrative

Based on the reported concern from the customer that a ¿blue fiber¿ reportedly from the cataract pack/sey54ctphl was found in the patient¿s eye after cataract surgery; an investigation into all three potential components, drape, gown and back table cover were reviewed even though the customer believed the fiber came from the gown.A sample of a piece of blue material which was identified as a piece of sms material used as a reinforcement in the back table cover was provided by the customer and no other samples were provided for the gown or the drape.Based on the sample received we were not able to confirm linting from the piece of blue material provided; therefore no further evaluation could be conducted.Therefore; based on the sample received and no further information available we are unable to determine the root cause for the issue reported.At this time no further action will be taken, but we will continue to monitor for any similar reported issues.

• Brand Name: CATARACT PACK (CTPHK)269
• Type of Device: 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: 7168861
• MDR Text Key: 96582928
• Report Number: 1423537-2018-00146
• Device Sequence Number: 1
• Product Code: LRO
• UDI-Device Identifier: 10887488840987
• UDI-Public: 10887488840987
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 03/14/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/05/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: SEY54CTPHL
• Device Catalogue Number: SEY54CTPHL
• Device Lot Number: 809440
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/08/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 67 YR