MAUDE Adverse Event Report: SYNERGY HEALTH DOUBLE BASIN PACK; DRAPE, SURGICAL

Device Problem Device Contamination with Chemical or Other Material (2944)

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

Event Date 10/09/2017

Event Type  malfunction  

Event Description

Prior to patient entering the room for a procedure, the surgical tech found a golden hair wrapped around a bowl within a synergy double basin.The hair and all items that were touched were removed from the field, and the contaminated area was covered to maintain sterile technique.

• Brand Name: DOUBLE BASIN PACK
• Type of Device: DRAPE, SURGICAL
• Manufacturer (Section D): SYNERGY HEALTH; 3903 northdale boulevard; suite 102e; northdale FL 33624
• MDR Report Key: 6968435
• MDR Text Key: 89959934
• Report Number: 6968435
• Device Sequence Number: 1
• Product Code: KKX
• 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: 10/09/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/23/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/09/2017
• Event Location: Hospital
• Date Report to Manufacturer: 10/09/2017
• 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