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

Model Number DYNJ51804A

Device Problem Device Contaminated During Manufacture or Shipping (2969)

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

Event Date 12/29/2016

Event Type  malfunction  

Event Description

Two av fistula packs were discovered to have contaminants in the pack upon opening them.These events were not necessarily from the same surgical case.They were reported to clinical engineering from an osf (outside facility).The packaging was saved from each of the packs and a new pack was opened to complete the procedure.

• 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: 6325325
• MDR Text Key: 67233977
• Report Number: 6325325
• 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: 01/18/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/13/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 07/31/2018
• Device Model Number: DYNJ51804A
• Device Catalogue Number: DYNJ51804A
• Device Lot Number: 16SB8811
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/18/2017
• Device Age: 1 DY
• Event Location: Hospital
• Date Report to Manufacturer: 01/18/2017
• 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