MAUDE Adverse Event Report: O&M HALYARD, INC. KIMGUARD ONE-STEP* QUICK CHECK* STERILIZATION WRAP, KC 500, 48IN X 48IN

Model Number	34148
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The product involved in the event was not available for return.A follow-up report will be provided upon conclusion of investigation.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.Device not returned.
Event or Problem Description
Customer stated, they had a delay in surgery due to tears in the wrap (during use with patients in the operating room).This was resolved by replacing the trays.In one instance the tray was one of a kind and they had to wait an hour and a half for sterile processing to replace the tray.No injury was reported to the patient.The customer reported that the patient had to be woken up from anesthesia.No instruments from the trays were reported as used on patients.
Additional Manufacturer Narrative
A sample or a lot number was not provided for this incident.Root cause was not identified.Walk-through inspections are regularly performed.In the event an issue is detected, the equipment is evaluated for any maintenance needs.All material is reworked since the last acceptable walk-through inspection.This incident will be included in complaint review analysis to help identify any emerging trends.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: STERILIZATION WRAP
• Manufacturer (Section D): O&M HALYARD, INC.; 1 edison drive; alpharetta GA 30005
• Manufacturer (Section G): HALYARD NORTH CAROLINA, LLC; 389 clyde fritzgearld road; linwood NC 27229
• Manufacturer Contact: nichole early ; 1 edison drive; alpharetta, GA 30005 ; 8287820529
• MDR Report Key: 17076048
• Report Number: 1054380-2023-00005
• Device Sequence Number: 6841805
• Product Code: FRG
• UDI-Device Identifier: 30680651341489
• UDI-Public: 30680651341489
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K214007
• 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): 07/19/2023

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: 34148
• Device Catalogue Number: 991034148
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• 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: 05/11/2023
• Supplement Date Received by Manufacturer: 06/22/2023
• Initial Report FDA Received Date: 06/06/2023
• Supplement Report FDA Received Date: 07/19/2023
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown