MAUDE Adverse Event Report: O&M HALYARD, INC KIMGUARD ONE-STEP QUICK CHECK STERILIZATION WRAP KC 400 48IN X 48IN; STERILIZATION PRODUCTS

Model Number	34145
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/08/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The sample is available for evaluation but has not been returned yet at the time of this report.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 an o&m halyard, inc.Product is defective or has caused serious injury.
Event or Problem Description
Hip replacement procedure was scheduled for patient on (b)(6) 2024.Clinician was unable to perform procedure at scheduled time because holes were found in the sterilization wrap covering surgical tray.Patient was not impacted other than annoyed by having to reschedule procedure.The patient was not sedated at the time of discovery.The complaint site indicated the holes were not noted prior to wrapping instrument tray in cssd.The trays had been stored by them for a week prior to case.O&m sales rep is conducting training with the site on best practices for managing sterilization trays to minimize risk of causing holes in wrap.
Additional Manufacturer Narrative
Sample was not available for evaluation.A dhr (device history record) review was conducted.There were fabric checks completed, no issues were documented.All visual checks were passing.The customer indicated there were no holes observed before or after wrapping in cssd.The trays that had been stored were placed and stored correctly.They also stated there were no holes or defects before sending them to procedure room for the scheduled operation.Owens and minor will provide site with additional education on best practices for handling of sterilized procedure trays.We were unable to identify a root cause, quality records indicate the material met specifications.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.

• Brand Name: KIMGUARD ONE-STEP QUICK CHECK STERILIZATION WRAP KC 400 48IN X 48IN
• Common Device Name: STERILIZATION PRODUCTS
• Manufacturer (Section D): O&M HALYARD, INC; 1 edison drive; alpharetta GA 30005
• Manufacturer (Section G): HALYARD NORTH CAROLINA, LLC; 389 clyde fitzgerald road; linwood NC 27299
• Manufacturer Contact: nichole early ; 1 edison drive; alpharetta, GA 30005 ; 8287820529
• MDR Report Key: 19094107
• Report Number: 1054380-2024-00003
• Device Sequence Number: 12598696
• Product Code: FRG
• UDI-Device Identifier: 30680651341458
• UDI-Public: 30680651341458
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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): 05/13/2024

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: 34145
• Device Catalogue Number: 34145
• Device Lot Number: LT32980000
• 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: 03/18/2024
• Supplement Date Received by Manufacturer: 04/29/2024
• Initial Report FDA Received Date: 04/11/2024
• Supplement Report FDA Received Date: 05/13/2024
• 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