MAUDE Adverse Event Report: AMERICAN CONTRACT SYSTEMS CUSTOM MINOR PACK; GENERAL SURGERY TRAY

Catalog Number GIMI55D

Device Problem Contamination of Device Ingredient or Reagent (2901)

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

Event Date 09/03/2019

Event Type  malfunction  

Event Description

When setting up for surgical procedure the instrument person discovered a foreign product on the blue towels.It appeared to be a splinter of wool.The pt had not entered the room yet when the debris was discovered.Fda safety report id# (b)(4).

• Brand Name: CUSTOM MINOR PACK
• Type of Device: GENERAL SURGERY TRAY
• Manufacturer (Section D): AMERICAN CONTRACT SYSTEMS
• MDR Report Key: 9028225
• MDR Text Key: 158651209
• Report Number: MW5089762
• 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: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/12/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/18/2020
• Device Catalogue Number: GIMI55D
• Device Lot Number: 801191
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/10/2019
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1