MAUDE Adverse Event Report: CARDINAL HEALTH 200, LLC FLEXAL; POLYMER PATIENT EXAMINATION GLOVE

Model Number 88TN03M

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

Event Date 11/06/2023

Event Type  malfunction  

Event Description

Multiple gloves pulled out of box in succession had holes in them.Lots no: cn05aa2mo13, mfg date: [redacted date] size medium gloves discarded.Manufacturer response for exam gloves, (brand not provided) (per site reporter) other sample from recent event is available for rep.Site coordinating with rep [redacted name] to return product.[redacted name] filed a complaint with the cardinal health quality team on [redacted date] after we emailed on [redacted name] about two recurring problems with the gloves.

• Brand Name: FLEXAL
• Type of Device: POLYMER PATIENT EXAMINATION GLOVE
• Manufacturer (Section D): CARDINAL HEALTH 200, LLC; 3651 birchwood drive; waukegan IL 60085
• MDR Report Key: 18491351
• MDR Text Key: 332618438
• Report Number: 18491351
• Device Sequence Number: 1
• Product Code: LZA
• 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: 11/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/11/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 88TN03M
• Device Catalogue Number: 88TN03M
• Device Lot Number: CN05AA2MO13
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/07/2023
• Event Location: Hospital
• Date Report to Manufacturer: 01/11/2024
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1