MAUDE Adverse Event Report: UNKNOWN PERI GYN PACK-LF; PERI TRAY

Lot Number (10) 22BBT772

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

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/08/2022

Event Type  malfunction  

Event Description

Black spec found in prep tray after chg had been poured ¿ not sure if it was from the prep kit or the chg bottle.Both items quarantined and removed from operation room ¿ did not touch patient.

• Brand Name: PERI GYN PACK-LF
• Type of Device: PERI TRAY
• Manufacturer (Section D): UNKNOWN
• MDR Report Key: 15322369
• MDR Text Key: 299045253
• Report Number: MW5111807
• Device Sequence Number: 1
• Product Code: OKV
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 07/14/2022

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: Health Professional
• Device Lot Number: (10) 22BBT772
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/29/2022
• Patient Sequence Number: 1
• Patient Sex: Male