MAUDE Adverse Event Report: O&M HALYARD, INC. HALYARD* POLYISOPRENE MICRO SURGICAL GLOVES; SURGICAL GLOVES POLYISOPRENE

Model Number	48317
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	05/09/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The product involved in the event was not available for return.The complaint component surgical polyisoprene gloves, part number: 48317 is manufactured by ansell (fda registration: 8041180).A supplier corrective action (scar) was submitted to the manufacturer on 12may2023.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
An incident occurred several times during donning of the gloves prior to use and after use with patients.There was no medical intervention/injury or employee health visits that occurred on the part of the user or patient.The holes were found in the gloves not the sterile packaging.
Additional Manufacturer Narrative
Correction: please note, the report was a malfunction for which o&m halyard is not the legal manufacturer but we are the initial importer.The legal manufacturer has been made aware.O&m halyard filed initial report with the fda in error.Per 21 cfr 803.40, importers are required to send reports of device-related deaths and serious injuries to fda.This complaint is a malfunction whereby no serious injury or death was reported.The device involved in this complaint was not returned for evaluation.The manufacturer (ansell) has replied to o&m halyard supplier corrective action request indicating that investigation was limited due to no lot number or samples provided.The manufacturer indicated that the calcium carbonate type changed from precarb+superlite to superlite ground calcium carbonate in february 2023.Without an indicated lot number, the manufacturer isn't sure this complaint incident involved a lot manufactured before or after this change.They will be monitoring all complaints for this product type to ensure there are no trend(s) for this issue.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.H3 other text: device not returned.

• Common Device Name: SURGICAL GLOVES POLYISOPRENE
• Manufacturer (Section D): O&M HALYARD, INC.; 1 edison drive; alpharetta GA 30005
• Manufacturer (Section G): ANSELL HEALTHCARE PRODUCTS, LLC; 1635 industrial road; dothan AL 36303
• Manufacturer Contact: nichole early ; 1 edison drive; alpharetta, GA 30005 ; 8287820529
• MDR Report Key: 17088544
• Report Number: 3014421917-2023-00005
• Device Sequence Number: 14929223
• Product Code: KGO
• UDI-Device Identifier: 30680651483172
• UDI-Public: 30680651483172
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K071746
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/30/2023
• Report Date (Section F): 05/12/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 48317
• Device Catalogue Number: 104831700
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 08/02/2023
• Event Location: Hospital
• Date Report to Manufacturer: 05/12/2023
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/09/2023
• Supplement Date Received by Manufacturer: 08/02/2023
• Initial Report FDA Received Date: 06/08/2023
• Supplement Report FDA Received Date: 08/31/2023
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown