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

Model Number PHS747474000

Device Problems Hole In Material (1293); Tear, Rip or Hole in Device Packaging (2385)

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

Event Date 01/18/2017

Event Type  malfunction  

Event Description

During set up for a case, it was noticed that the sterile table cover in a basic pack had a rip at the seam causing a big hole.Per site reporter, medline will report a quality issue and start an investigation.They will also replace the product at no expense.

• Brand Name: MEDLINE INDUSTRIES, INC.
• Type of Device: GENERAL SURGERY TRAY
• Manufacturer (Section D): MEDLINE INDUSTRIES, INC.; 1170 s northpoint blvd.; waukegan IL 60085
• MDR Report Key: 6553539
• MDR Text Key: 74724457
• Report Number: 6553539
• 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: 01/19/2017,05/08/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/09/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 01/01/2021
• Device Model Number: PHS747474000
• Device Catalogue Number: PHS747474000
• Device Lot Number: 16WB7789
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/19/2017
• Device Age: 1 DY
• Event Location: Hospital
• Date Report to Manufacturer: 01/19/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1