MAUDE Adverse Event Report: BASIC MEDICAL INDUSTRIES, INC. BASIC VINYL SYNMAX EXAM GLOVES; VINYL PATIENT EXAMINATION GLOVE

Model Number BMPF 3002

Device Problems Material Puncture/Hole (1504); Material Separation (1562); Material Split, Cut or Torn (4008)

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

Event Date 02/15/2021

Event Type  malfunction  

Event Description

Vinyl gloves have been noted to easily rip, separate and form holes after only minutes of normal use.Also, upon donning the gloves: the wrist area pulls out and is easily torn and during normal use the finger-tips are essentially separating.Also noted is a thin and easily-stressed line between the inner line in the vinyl of the thumb-to-forefinger region then splitting upon donning the glove.Each glove, however, is different in its "breaks".Laboratory has noted issue with multiple boxes as has the observation floor.Staff is concerned for the safety of the patients and the associates as well.Nursing has alerted our internal supply chain and they all appreciate the glove availability/status world-wide.When collecting the information and sample boxes from the floors it was necessary to leave the only-available products on the nursing floor so they had something with which to work as there is no option of replacement at the present time.No patient nor associate harms noted.There are manufactured dates listed on the boxes but no expiration dates: all the samples pulled and listed in this report manufactured in 2020 and range from may through october of 2020.

• Brand Name: BASIC VINYL SYNMAX EXAM GLOVES
• Type of Device: VINYL PATIENT EXAMINATION GLOVE
• Manufacturer (Section D): BASIC MEDICAL INDUSTRIES, INC.; 12390 east end ave; chino CA 91710
• MDR Report Key: 11473448
• MDR Text Key: 239483771
• Report Number: 11473448
• 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: Risk Manager
• Type of Report: Initial
• Report Date: 02/19/2021,02/18/2020

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: Other
• Device Model Number: BMPF 3002
• Device Lot Number: 3593973-8
• 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: 02/19/2021
• Device Age: 0 YR
• Event Location: Hospital
• Date Report to Manufacturer: 03/12/2021
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/12/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1