MAUDE Adverse Event Report: MEDLINE INDUSTRIES, INC. OR STERILE SPECIMEN CONTAINER; CONTAINER, SPECIMEN, STERILE

Catalog Number DYND30331

Device Problems Material Discolored (1170); Delivered as Unsterile Product (1421); Out-Of-Box Failure (2311)

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

Event Date 08/17/2015

Event Type  malfunction  

Event Description

Lid of specimen container had brownish/yellowish spots scattered on both the top and underneath.Spots do not come off.Came out of sterile packaging this way.

• Brand Name: OR STERILE SPECIMEN CONTAINER
• Type of Device: CONTAINER, SPECIMEN, STERILE
• Manufacturer (Section D): MEDLINE INDUSTRIES, INC.; one medline place; mundelein IL 60060
• MDR Report Key: 5127089
• MDR Text Key: 27460208
• Report Number: 5127089
• Device Sequence Number: 1
• Product Code: KDT
• 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: Patient
• Report Date: 09/16/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/05/2015
• Is this an Adverse Event Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: DYND30331
• Device Lot Number: 96915040001
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/16/2015
• Event Location: Hospital
• Date Report to Manufacturer: 09/16/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1