MAUDE Adverse Event Report: MEDLINE INDUSTRIES, INC.; MINOR TRAY

Catalog Number DYNJ25959K

Device Problem Component Falling (1105)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/21/2016

Event Type  Injury  

Manufacturer Narrative

It was reported that threads came off of the 4x4 gauze and entered into a surgical site.The threads were removed manually using forceps.The gauze was unfolded during use.No injury or further intervention was reported.The sample was not retained for evaluation.A root cause has not been determined.However, due to the reported incident and in an abundance of caution, this medwatch is being filed.

Event Description

The facility reported that threads from the 4x4 gauze fell into the incision site.

• Type of Device: MINOR TRAY
• 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: 5453911
• MDR Text Key: 38781365
• Report Number: 1423395-2016-00016
• 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,user faci
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 02/23/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/23/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: DYNJ25959K
• Device Lot Number: 15KB3867, 15KB4288
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Ambulatory Surgical Facility
• Date Manufacturer Received: 01/27/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/01/2015
• 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
• Patient Age: 63 YR