MAUDE Adverse Event Report: O&M HALYARD, INC. HALYARD PURPLE NITRILE-XTRA POWDER-FREE EXAM GLOVES S; EXAM GLOVES NITRILE PURPLE

Model Number	50601M
Medical Device Problem Codes	Defective Device (2588); Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/25/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The product involved in this event is available for evaluation.This product incident is documented in the o&m halyard, inc.Complaint database and identified as complaint (b)(4).This information is submitted pursuant to 21cfr803, in compliance with the medical device reporting requirement and should not be considered to be an admission that an o&m halyard, inc.Product is defective or has caused serious injury.
Event or Problem Description
Holes were reported to be found on the gloves and an employee came in contact with hepatitis b.The customer stated there was no medical intervention and there were no injuries reported.Employee was tested for hepatitis b upon awareness of issue.Additional information was requested on october 31, 2024, and it was reported the employee is currently fine and will have a follow up blood test on (b)(6) 2024 for hepatitis b.
Additional Manufacturer Narrative
Returned sample review: returned complaint lot samples were evaluated, no defects were found.Retained sample review: the retained sample for complaint batch was tested by visual inspection, no visual defects were found.A device history record review of complaint lot was performed, the product was produced in accordance with process procedures and found to meet in-process and final release criteria.Additionally, the information provided by customer indicated that they were using this glove with bodedex, the chemical protection on the dispenser box does not state that this glove can be used with this chemical.This product incident is documented in the o&m halyard, inc.Complaint database and identified as complaint comp-(b)(4).This information is submitted pursuant to 21cfr803, in compliance with the medical device reporting requirement and should not be considered to be an admission that an o&m halyard, inc.Product is defective or has caused serious injury.

• Brand Name: HALYARD PURPLE NITRILE-XTRA POWDER-FREE EXAM GLOVES S
• Common Device Name: EXAM GLOVES NITRILE PURPLE
• Manufacturer (Section D): O&M HALYARD, INC.; 1220 old alpharetta rd; ste 320; alpharetta GA 30005
• Manufacturer (Section G): SAFESKIN MEDICAL & SCIENTIFIC (THAILAND), LTD.; 200 moo 8 kanchanavanich road; tambol prik; sadao songkhla, th 90120 ; TH 90120
• Manufacturer Contact: nichole coggins ; 1220 old alpharetta rd; ste 320; alpharetta, GA 30005 ; 8287820529
• MDR Report Key: 20679807
• Report Number: 9614175-2024-00004
• Device Sequence Number: 15592794
• Product Code: LZC
• UDI-Device Identifier: 20680651504825
• UDI-Public: 20680651504825
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K160709
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/31/2024

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
• Operator of Device: Health Professional
• Device Model Number: 50601M
• Device Catalogue Number: 50482
• Device Lot Number: SM4043ZZZ_33CX
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/25/2024
• Supplement Date Received by Manufacturer: 12/09/2024
• Initial Report FDA Received Date: 11/13/2024
• Supplement Report FDA Received Date: 12/31/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown