MAUDE Adverse Event Report: O&M HALYARD, INC. KIMGUARD ONE-STEP QUICK CHECK STERILIZATION WRAP 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	03/14/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Holes were found on the sterilization wrap which caused a delay in procedure.The procedure was postponed to later in the day.There were no holes observed before or after wrapping.The trays had been stored for a week and were placed and stored correctly according to customer.They were also observed to have no holes or defects before sending them to theatre for the scheduled operation.The patient had not been sedated at the time of discovery.
Additional Manufacturer Narrative
Sample was not available for evaluation.During the manufacturing process of this product, two separate sheets of (blue and white) rolled material which are produced on separate days are brought together and bonded; thus, it would be considered highly unlikely for these two separate sheets to line up together and have an exact location of holes.According to quality records, the material met specifications.All visual checks were documented as "pass." there were no reported nonconformances.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, and if applicable, additional investigation will be initiated and corrective actions assigned.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 an o&m halyard, inc.Product is defective or has caused serious injury.H3 other text : device not returned.

• Brand Name: KIMGUARD ONE-STEP QUICK CHECK STERILIZATION WRAP 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: 19646210
• Report Number: 1054380-2024-00012
• Device Sequence Number: 6557916
• 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
• Report Date (Section B): 07/01/2024

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: 03/19/2024
• Initial Report FDA Received Date: 07/01/2024
• 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