MAUDE Adverse Event Report: O&M HALYARD, INC. KIMGUARD ONE-STEP QUICK CHECK STERILIZATION WRAP KC 500

Model Number	34148
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
Event or Problem Description
Customer reported several wraps had pin holes in them.The holes caused a delay in procedure and reprocessing of procedure trays.Additional information was received from the customer on february 15, 2024.No instruments were used.The holes were caught before the cases were started.Delays varied.Some of them we had backup instruments available and did not cause a delay in the case.We did not keep record of the delays on our end.I know our staff was encouraged to write uors if there were significant delays to patient care.We cannot give an exact number of procedures or the dates that this occurred, all we did was report the incidences as they were occurring.
Additional Manufacturer Narrative
Six samples were received for evaluation with no product packaging.The samples were evaluated under ambient light conditions.All six (6) samples arrived with circled areas on the blue and white layers.There are material damages and holes in these areas and the fibers appear scraped and abraded.All six (6) samples exhibit heavy creases and folds.There are also distinct indentations which appear like outlines of what could be instrument trays.The holes do not penetrate through both layers in most cases.The holes are primarily on the blue layers and present as areas where the material appears scraped.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.
Additional Manufacturer Narrative
Six (6) used samples were received with no product packaging.There is sterilization indicator tape affixed to the surface of the blue layer on all the samples.There are medical procedure labels affixed to the blue layer on all the samples.The samples were evaluated under ambient light conditions.All six (6) samples arrived with circled areas on the blue and white layers.There are material damages and holes in these areas and the fibers appear scraped and abraded.Evaluations as follows: all six (6) samples exhibit heavy creases and folds.There are also distinct indentations which appear like outlines of what could be instrument trays.The holes, the abraded fibers and what appears as scraped material present similarly on all the samples.The damaged areas, whether a hole, a scraped appearance of the material or the abraded fibers are located in the areas of the samples where there are creases or where there is an outline of what could be an instrument tray.The holes do not penetrate through both layers in most cases.The holes are primarily on the blue layers and present as areas where the material appears scraped.The fibers on the scraped areas appear abraded and the edges of the holes appear irregular and jagged.There are some damaged spots which appear as if the material has been flattened.These areas appear shiny, and the bond pattern is flat.When the white layers are inspected on the corresponding spots where there is a hole on the blue layer, no holes are observed.There are in some cases a slightly flattened spot, but no distinct holes are observed on the white layers.Many of the holes and the damaged areas were viewed under magnification.From the attached photos and sample evaluation, all of the samples received were post sterilized.All six samples contained damage and holes and the fibers appear scraped and abraded.All six samples exhibit heavy creases and folds.There were distinct indentations which appear like outlines of what could be instrument trays.All six samples had the sterilization indicator tape still adhered to the material with medical procedure labels affixed to the blue layer on all the samples.The complaint details were forwarded to the appropriate functional area for investigation and root cause determination.The manufacturing plant could not identify the source of the holes as the manufacturing process requires two separate rolls of wrap material be brought together to bond.It would be difficult to align two separate sheets to form holes.No additional actions will be implemented at this time as the material was shown to meet specification during in-process inspection.Complaint metrics are analyzed monthly to evaluate for any trends and corrective action needs.Should a trend present, corrective action would be initiated to remediate.A root cause could not be 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.

• Brand Name: KIMGUARD ONE-STEP QUICK CHECK STERILIZATION WRAP KC 500
• Common Device Name: STERILIZATION WRAP
• 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: 18773011
• Report Number: 1054380-2024-00002
• Device Sequence Number: 4462371
• Product Code: FRG
• UDI-Device Identifier: 30680651341489
• UDI-Public: 30680651341489
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): 03/29/2024

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
• Device Model Number: 34148
• Device Catalogue Number: 991034148
• Device Lot Number: LT3333
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/30/2024
• 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: 01/24/2024
• Supplement Date Received by Manufacturer: 03/12/2024
• Initial Report FDA Received Date: 02/23/2024
• Supplement Report FDA Received Date: 03/29/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• 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