MAUDE Adverse Event Report: O&M HALYARD, INC. KIMGUARD ONE-STEP* QUICK CHECK* STERILIZATION WRAP, KC 600, 45IN X 45IN; HALYARD* QUICK CHECK* STERILIZATION WRAP

Model Number	34164
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 is 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.
Event or Problem Description
The facility has experienced holes in the wrap post sterilization.They are using corner protectors, and the holes are occurring on the middle and sides of the wraps on the white side.The customer confirmed the weight of the trays are 17-25 pounds and they are using the wraps according to the instructions for use.The customer stated they experienced a delay in a procedure that last less than a half hour.It was resolved by taking a tray from another case.
Additional Manufacturer Narrative
The product involved in the event was not returned for evaluation.This complaint was reviewed by the manufacturing site.The customer stated, "holes in the wrap post sterilization".There were no qnc events associated with the complaint lot, device history record review found the product met manufacturing specification at release.Customer feedback is reviewed by the complaint review board which utilizes metrics such as cpm (complaints per million) and trend analysis to monitor the effectiveness of the process and quality control.This incident will be included in our complaint review analysis to help identify any emerging trends.A root cause was not identified.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: HALYARD* QUICK CHECK* 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: 17749067
• Report Number: 1054380-2023-00006
• Device Sequence Number: 4184655
• Product Code: FRG
• UDI-Device Identifier: 30680651341649
• UDI-Public: 30680651341649
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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): 10/30/2023

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: 34164
• Device Catalogue Number: 991034164
• Device Lot Number: LT3121000
• 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: 08/29/2023
• Supplement Date Received by Manufacturer: 10/06/2023
• Initial Report FDA Received Date: 09/14/2023
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown