MAUDE Adverse Event Report: MEDLINE INDUSTRIES, INC.; CATARACT PACK

Catalog Number VAL011CTASA

Device Problem Physical Property Issue (3008)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/07/2016

Event Type  Injury  

Manufacturer Narrative

The facility reported that fibers came off of the back table cover and were found in the surgical site.The particulate was removed from the surgical site using suction at the end of the procedure.There was no serious injury or need for any additional intervention.We have not identified any trends for this issue with this component.We have not received a sample for evaluation.A root cause has not been determined, however due to the need for an intervention this medwatch is being filed.

Event Description

The facility reported that fibers came off of the back table cover and were found in the surgical site.

• Type of Device: CATARACT PACK
• Manufacturer (Section D): MEDLINE INDUSTRIES, INC.; one medline place; mundelein IL 60060
• Manufacturer Contact: diane christensen ; one medline place; mundelein, IL 60060 ; 8476434747
• MDR Report Key: 5415889
• MDR Text Key: 37628314
• Report Number: 1423395-2016-00008
• Device Sequence Number: 1
• Product Code: LRO
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 02/08/2016

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
• Device Operator: Health Professional
• Device Catalogue Number: VAL011CTASA
• Device Lot Number: 15VB6029
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Event Location: Ambulatory Surgical Facility
• Initial Date Manufacturer Received: 01/11/2016
• Initial Date FDA Received: 02/08/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/01/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other