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

Model Number	34145
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/15/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Wrapping sheets exhibited micro-perforations after sterilization and were already damaged upon removal from the package prior to use.As a result, multiple surgical procedures were delayed after patients were already positioned on the operating table.Additional details (including patient details for those affected) have been requested; however, no further details have been provided to-date.
Additional Manufacturer Narrative
The sample is said to be available for evaluation but not received yet.A follow-up report will be provided upon conclusion of the 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.
Additional Manufacturer Narrative
Three unused samples were received for evaluation.Based on the attached photographs and sample assessment, the material exhibits defects on the blue layer around the bond points, likely caused by poor spinning in the form of spitters.No holes were observed in the inspected defect areas, and the white layers do not appear to be affected.All three samples arrived with areas of concern circled in pink ink on the blue layer.Within these circled areas, dark blue spots measuring approximately 1 mm or less were observed, primarily around the bond points.One dark spot from each sample was examined under magnification.Although no obvious holes were identified during the inspection, the presence of breaches within the damaged areas cannot be completely ruled out.The white layers remain unaffected.Hard spots/spitters are spinning defects inherent to the manufacturing process.They can occur when polymer fibers break during extrusion, when turbulence affects the web, or when excessive temperatures cause polymer granules to harden and clog the extrusion tips.These clogs increase extruder pressure until it releases, pushing small hardened particles (spitters) onto the sheet.When such conditions are observed during visual inspections, production associates immediately notify the appropriate personnel to determine corrective actions.Controls used to minimize polymer blemishes include established process settings with defined limits, center lining control plans, automated process monitoring systems, and statistical process controls.Process and product testing results are closely monitored to guide actions.Customer feedback is reviewed by the complaint review board, which uses metrics such as cpm (complaints per million) and trend analysis to evaluate process and quality performance.This product incident is documented in the complaint database and identified as complaint (b)(4).This information is submitted pursuant to 21 cfr 803, in compliance with the medical device reporting requirement and should not be considered to be an admission that product is defective or caused serious injury.

• Brand Name: KIMGUARD ONE-STEP QUICK CHECK STERILIZATION WRAP KC 400 48 IN
• Common Device Name: STERILIZATIONS PRODUCTS
• Manufacturer (Section D): O&M HALYARD, INC.; 1220 old alpharetta rd.; ste 320; alpharetta GA 30005
• Manufacturer (Section G): HALYARD NORTH CAROLINA, LLC; 389 clyde fitzgerald rd; linwood NC 27299
• Manufacturer Contact: nichole coggins ; 1220 old alpharetta rd; ste 320; alpharetta, GA 30005 ; 8287820529
• MDR Report Key: 24222485
• Report Number: 1054380-2026-00001
• Device Sequence Number: 21173675
• Product Code: FRG
• UDI-Device Identifier: 30680651341458
• UDI-Public: 30680651341458
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• PMA/510(K) Number: K234050
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/18/2026

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: LT5028000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/22/2026
• Supplement Date Received by Manufacturer: 03/13/2026
• Initial Report FDA Received Date: 01/30/2026
• Supplement Report FDA Received Date: 03/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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