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

Catalog Number DYNJP5000

Device Problems Device Packaging Compromised (2916); Device Contamination with Chemical or Other Material (2944)

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

Event Date 03/29/2016

Event Type  malfunction  

Event Description

Upon opening a sterile pack to be used for surgery, a dead bug was found inside the pack.

• Brand Name: CYSTOSCOPY PACK I
• Type of Device: GENERAL SURGERY TRAY
• Manufacturer (Section D): MEDLINE INDUSTRIES, INC.; one medline place; mundelein IL 60060
• MDR Report Key: 5569540
• MDR Text Key: 42410001
• Report Number: 5569540
• Device Sequence Number: 1
• Product Code: EZL
• 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: 03/30/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/12/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: DYNJP5000
• Device Lot Number: 31115030019H
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/30/2016
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/30/2016
• Event Location: Hospital
• Date Report to Manufacturer: 03/30/2016
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1