MAUDE Adverse Event Report: CW INTERNATIONAL SALES LLC. SAFEGUARD; VINYL PATIENT EXAMINATION GLOVE

Lot Number LIG-TPCNE-402

Device Problem Material Puncture/Hole (1504)

Patient Problem Insufficient Information (4580)

Event Date 06/16/2022

Event Type  malfunction  

Event Description

Writer went to give injectable medication and applied gloves.While writer was administering injection, writer noticed that there was a small hole in the glove that writer didn't feel or notice until in process of administering injection.Hole was on lateral edge of middle finger.Multiple people have stated that they have been having issues with these types of gloves and another kind of gloves that are on the unit.

• Brand Name: SAFEGUARD
• Type of Device: VINYL PATIENT EXAMINATION GLOVE
• Manufacturer (Section D): CW INTERNATIONAL SALES LLC.; 600 james street; lakewood NJ 08701
• MDR Report Key: 15437780
• MDR Text Key: 300043011
• Report Number: 15437780
• Device Sequence Number: 1
• Product Code: LYZ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 09/12/2022

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: LIG-TPCNE-402
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/12/2022
• Event Location: Hospital
• Date Report to Manufacturer: 09/16/2022
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/16/2022
• Type of Device Usage: Unknown
• Patient Sequence Number: 1