MAUDE Adverse Event Report: MEDLINE INDUSTRIES TROY MAJOR KIT; CUSTOM SURGICAL PACK

Catalog Number DYNJ54802B

Device Problems Break (1069); Detachment Of Device Component (1104); Crack (1135); Component Missing (2306)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/01/2018

Event Type  malfunction  

Event Description

The pitcher in the major pack was cracked with a plastic piece broken off of it.Plastic piece was not found in the basin of the major pack.The broken pitcher was noticed before the surgery began, and was replaced.Clinical engineering received the pitcher for investigation, photographed the crack in the pitcher, and passed the product along to the medline rep for quality investigation.Per site reporter: the manufacturer field representative retrieved the device and opened a quality complaint.The device is currently under investigation.

• Brand Name: TROY MAJOR KIT
• Type of Device: CUSTOM SURGICAL PACK
• Manufacturer (Section D): MEDLINE INDUSTRIES; 1 medline place; mundelein IL 60060
• MDR Report Key: 7384788
• MDR Text Key: 103986637
• Report Number: 7384788
• 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: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/30/2018
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: DYNJ54802B
• Device Lot Number: 17LD2631
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/27/2018
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/27/2018
• Device Age: 0 YR
• Event Location: Hospital
• Date Report to Manufacturer: 03/27/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 33 YR
• Patient Weight: 59