MAUDE Adverse Event Report: O&M HALYARD, INC. KIMGUARD ONE-STEP* QUICK CHECK* STERILIZATION WRAP, KC 500, 24IN X 24IN; STERILIZATION PRODUCTS

Model Number	34162
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
Correction: the initial emdr was submitted under the incorrect mfr report number 1053279-2023-00004 and the correct mfr report number.Forty-four (44) unused samples were received with no product packaging for lot number: lr3091000.The samples were evaluated under ambient light conditions and arrived inside a cardboard box.The samples arrived individually folded in fours.The samples were removed from the box and stacked with the white layer facing up on the lab table.Each sample exhibits numerous nicks or what can be described as slits.The affected areas appear in the same location on each sample.The slits occur in intermittent spacings along the entire 24 inches in the md of each sample.Some slits affect the white layer only and other slits affect both layers.The slits align on the layers.The complaint details were forwarded to the appropriate functional area for investigation and root cause determination.Based on the results of the investigation we confirmed the failure reported.The following potential root cause has been identified as an equipment issue.On-going actions are in place to minimize the opportunity for recurrence including additional audits performed.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.
Event or Problem Description
Customer stated, they had a delay of cases due to tears in the wrap (during use with patients in the or).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.

• 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 fritzgerald road; linwood NC 27299
• Manufacturer Contact: nichole early ; 1 edison drive; alpharetta, GA 30005 ; 8287820529
• MDR Report Key: 17252955
• Report Number: 1054380-2023-00003
• Device Sequence Number: 6831046
• Product Code: FRG
• UDI-Device Identifier: 30680651341625
• UDI-Public: 30680651341625
• 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
• Report Date (Section B): 07/03/2023

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: 34162
• Device Catalogue Number: 991034162
• Device Lot Number: LR3091000
• 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
• Initial Report FDA Received Date: 07/03/2023
• 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