MAUDE Adverse Event Report: SPS GLOBAL PREMIERPRO PLUS NITRILE EXAM GLOVES

Lot Number MTH05-12 L 5064

Device Problem Contamination of Device Ingredient or Reagent (2901)

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

Event Date 06/01/2019

Event Type  malfunction  

Event Description

The lot numbers that are listed in the next section are the affected numbers for the premier pro plus nitrile exam gloves.The gloves in these lot number have been found to have a significant amount of debris in the fingers when staff have attempted to put them on before pt care.No pts have been affected.

• Brand Name: PREMIERPRO PLUS NITRILE EXAM GLOVES
• Type of Device: EXAM GLOVES
• Manufacturer (Section D): SPS GLOBAL ; charlotte NC
• MDR Report Key: 8892584
• MDR Text Key: 154848728
• Report Number: 8892584
• Device Sequence Number: 15
• Product Code: LZC
• 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: Risk Manager
• Type of Report: Initial
• Report Date: 08/05/2019
• 15 Devices were Involved in the Event: 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15

1 Patient was Involved in the Event

• Date FDA Received: 08/07/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Lot Number: MTH05-12 L 5064
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/05/2019
• Distributor Facility Aware Date: 06/01/2019
• Event Location: Hospital
• Date Report to Manufacturer: 07/01/2019
• 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