MAUDE Adverse Event Report: AMERICAN CONTRACT SYSTEMS ANTERIOR HIP PACK; GENERAL SURGERY TRAY

Model Number CDMH06C-01

Device Problems Contamination of Device Ingredient or Reagent (2901); Device Contamination with Chemical or Other Material (2944)

Patient Problem No Code Available (3191)

Event Date 10/02/2017

Event Type  malfunction  

Event Description

Sterility of anterior hip surgical pack questioned and considered contaminated due to wood found within lap sponges located within the sterile surgical pack.Surgery cancelled by surgeon late in day.Outcome: 1.Delay of consumer service issue, for patient, patient's family, and physician.2.Cost issue: all supplies had to be wasted and all instrumentation had to be reprocessed / resterilized.

• Brand Name: ANTERIOR HIP PACK
• Type of Device: GENERAL SURGERY TRAY
• Manufacturer (Section D): AMERICAN CONTRACT SYSTEMS; 7802 e telecom pkwy; tampa FL 33637
• MDR Report Key: 6961099
• MDR Text Key: 89707321
• Report Number: 6961099
• 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: 10/10/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/19/2017
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: CDMH06C-01
• Device Lot Number: 867171
• 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: 10/10/2017
• Event Location: Hospital
• Date Report to Manufacturer: 10/10/2017
• 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
• Treatment: NOT APPLICABLE.
• Patient Age: 64 YR
• Patient Weight: 91