MAUDE Adverse Event Report: AMERICAN CONTRACT SYSTEMS CHEST TUBE PLACEMENT CUSTOM KIT; CUSTOM PROCEDURE SUPPLY KIT

Lot Number 893171

Device Problem Packaging Problem (3007)

Patient Problem No Information (3190)

Event Date 05/17/2017

Event Type  malfunction  

Event Description

Custom trays from american contract systems (various types) previously had lidocaine packaged inside the tray.However, the manufacturer now adds the lidocaine on the outside.Concern that the lidocaine might be separated from the tray yet it is still listed as contents and the user may not be aware with the main packaging intact.Also may be an unsafe way to store medication.

• Brand Name: CHEST TUBE PLACEMENT CUSTOM KIT
• Type of Device: CUSTOM PROCEDURE SUPPLY KIT
• Manufacturer (Section D): AMERICAN CONTRACT SYSTEMS; 904 bethel circle; waunakee WI 53597
• MDR Report Key: 6584055
• MDR Text Key: 75743296
• Report Number: 6584055
• 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: 05/17/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 04/17/2018
• Device Lot Number: 893171
• Other Device ID Number: 180417893171
• 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: 05/17/2017
• Device Age: 0 YR
• Event Location: Hospital
• Date Report to Manufacturer: 05/17/2017
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/23/2017
• 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