MAUDE Adverse Event Report: O&M HALYARD, INC. HALYARD * POLYISOPRENE/NEOPRENE HYBRID POWDER-FREE STERILE SURGICAL GLOVES; SURGICAL GLOVES POLYISOPRENE

Model Number	48327
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The product involved in the event was not available for return.The complaint component surgical polyisoprene gloves, part number 48327 is manufactured by ansell (fda registration 8041180).A supplier corrective action (scar) was submitted to the manufacturer on july 20, 2023.A follow-up report will be provided upon conclusion of investigation and response by the manufacturer.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 a o&m halyard, inc.Product is defective or has caused serious injury.
Event or Problem Description
The customer stated a hole developed during use with the nitrile glove.Attempts were made to acquire additional incident information on (b)(6) 2023.No additional details have been provided to-date.
Additional Manufacturer Narrative
The product involved in the event was not available for return.The complaint product was manufactured by ansell (fda registration: 8041180).O&m halyard, inc.Submitted initial mdr in error.O&m halyard, inc.Is the initial importer of device; however, there was no serious injury or illness (adverse event) associated with this complaint therefore pursuant to 21 cfr 803 a report to fda is not required by the initial importer.The manufacturer did respond to supplier corrective action request with investigation findings.No samples were provided by the customer.The retained samples were reviewed and no abnormalities were found.An investigation was carried out by reviewing all the data including production and packing device history records, complaint history and internal defect trends.The lot passed at 0.65 aql inspection.The manufacturer (ansell) implemented several corrective actions, including: validation to improve the homogeneity of coagulant application, new inspection checklist to inspect all formers, and a checklist has been established to monitor for sharp edges of glove bins and equipment.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 a o&m halyard, inc.Product is defective or has caused serious injury.

• Common Device Name: SURGICAL GLOVES POLYISOPRENE
• Manufacturer (Section D): O&M HALYARD, INC.; 1 edison drive; alpharetta GA 30005
• Manufacturer (Section G): ANSELL LANKA (PVT.), LTD.; biyagama export processing zo; biyagama gampaha, sri lanka ; CE
• Manufacturer Contact: nichole early ; 1 edison drive; alpharetta, GA 30005 ; 8287820529
• MDR Report Key: 17557991
• Report Number: 3014421917-2023-00007
• Device Sequence Number: 3600549
• Product Code: KGO
• UDI-Device Identifier: 30680651483271
• UDI-Public: 30680651483271
• Combination Product (Y/N): N
• Initial Reporter State: WV
• Initial Reporter Country: US
• PMA/510(K) Number: K151694
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 10/31/2023
• Report Date (Section F): 07/20/2023

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: 48327
• Device Catalogue Number: 104832700
• Device Lot Number: 2205083305
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 07/20/2023
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/17/2023
• Supplement Date Received by Manufacturer: 10/02/2023
• Initial Report FDA Received Date: 08/16/2023
• Supplement Report FDA Received Date: 10/31/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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