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

Lot Number 16XB9074

Device Problems Component Missing (2306); Packaging Problem (3007)

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

Event Date 06/05/2017

Event Type  malfunction  

Event Description

Expecting to find 10 raytec in pack and found only seven.Raytec is a countable item and comes in 10 pack always.Manufacturer response for raytec, lap gastric pack (per site reporter): will start qa process.Will send the hospital the steps for starting the process.

• Brand Name: LAP GASTRIC PACK
• Type of Device: GENERAL SURGERY TRAY
• Manufacturer (Section D): MEDLINE INDUSTRIES, INC.; 1170 s northpoint blvd.; waukegan IL 60085
• MDR Report Key: 6673189
• MDR Text Key: 78585443
• Report Number: 6673189
• 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: Patient
• Type of Report: Initial
• Report Date: 06/12/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 01/31/2018
• Device Lot Number: 16XB9074
• Other Device ID Number: CMPJ06173
• 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: 06/12/2017
• Event Location: Hospital
• Date Report to Manufacturer: 06/12/2017
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/28/2017
• 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