MAUDE Adverse Event Report: O&M HALYARD, INC. QUICK CHECK H600 STERILIZATION WRAP 48IN - 48IN; STERILIZATION PRODUCTS

Model Number	34147
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The sample was evaluated under ambient light conditions.The sample arrived with a circled area on the blue layer where there is an incomplete daisy pattern.The area measures approximately 1.2cm.The area was viewed under magnification.The area can be described as a flatter bond point area where the daisy pattern is not defined.The white layer is not affected.The complaint is undergoing further investigation by the manufacturing site, a follow up report will be submitted upon conclusion of investigation.This product incident is documented in the o&m halyard, inc.Complaint database and identified as complaint comp (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
Holes were found in the sterilization wrap at the time of or set up.Items had to be sent back to csr to be reprocessed.There was no injury or medical intervention required for patient(s).There was a delay in cases, in some instances, the delay was an hour or longer.
Additional Manufacturer Narrative
A complaint sample was evaluated under ambient light conditions.The sample arrived with a circled area on the blue layer where there is an incomplete daisy pattern.The area measures approximately 1.2cm.The area was viewed under magnification.The area can be described as a flatter bond point area where the daisy pattern is not defined.The white layer is not affected.The device history record for product was reviewed.Quality records showed the attributes and visual checks on the rolls were documented as pass.There were no documented issues.According to quality records, this material met specification guidelines.There can be times where polymer or particles can stick to the rolls.These small particles or debris of foreign material can transfer to the sheet, which can cause a hole, make an indention, or cause flattened areas on the sheet.Product testing is conducted utilizing a lot acceptance system and aql limits.Some of the process tools utilized to minimize issues include online web inspection detection devices, process settings with established run settings, center lining control plans, an automatic process monitoring system, and statistical process controls.Results of the process and product testing are closely monitored.Customer feedback is reviewed which utilizes metrics such as cpm (complaints per million) and trend analysis to monitor the effectiveness of process and quality control.No actions are taken at this time, the observation is considered a visual defect that does not affect the strength and durability of the fabric.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: QUICK CHECK H600 STERILIZATION WRAP 48IN - 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; 389 clyde fitzgerald road; linwood NC 27299
• Manufacturer Contact: nichole early ; 1 edison drive; alpharetta, GA 30005 ; 8287820529
• MDR Report Key: 19530263
• Report Number: 1054380-2024-00005
• Device Sequence Number: 7560567
• Product Code: FRG
• UDI-Device Identifier: 30680651341472
• UDI-Public: 30680651341472
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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): 07/25/2024

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: 34147
• Device Catalogue Number: 103414720
• Device Lot Number: LT4044
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/14/2024
• 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: 05/14/2024
• Supplement Date Received by Manufacturer: 07/16/2024
• Initial Report FDA Received Date: 06/13/2024
• Supplement Report FDA Received Date: 07/25/2024
• 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): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown