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

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
Three used samples were received for evaluation.One sample contained two circled areas on the blue layer, these areas did have holes present in the blue layer only.The damaged areas were present where there was a crease or fold.There was also a slit area (through both white and blue layers).Second sample had indentations appearing at the outline of the instrument tray.One hole was confirmed in the blue layer (white layer unaffected).Third sample also had similar indentations where the instrument tray was.One area had an irregular slit penetrating both blue and white layers.Additional follow up questions have been requested from the customer on 01/19/24, 01/26/24 and 01/30/24.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 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 a o&m halyard, inc.Product is defective or has caused 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 incident questions were asked of the customer on 01/19/24, 01/26/24, and 01/30/24.No response has been provided to-date.
Additional Manufacturer Narrative
Three (3) used samples were received with no product packaging.There is sterilization indicator tape affixed to the surface of the blue layers of all three samples.The samples were evaluated under ambient light conditions.The samples were laid out on the table with the blue layer facing up.There is sterilization indicator tape affixed to the surface of the blue layer.There are medical procedure labels affixed to the surface of the blue layer.There are circled areas on each sample indicating the areas of concern.There are three (3) samples.Evaluations as follows: sample 1: there are folds and heavy creases on the sample.There are also indentations on the sample which appear to be outlines of instrument trays.There are two circled areas on the blue layer.Both areas exhibit holes.The damaged areas are in the areas of creases and folds.One damaged area appears as a round hole on the blue layer.The round hole although it does not penetrate all the way through both layers, has the appearance of having damaged the white layer.When viewed under magnification, the fibers on the white layer appear damaged as if there is a possible breach.The other damaged area appears as a clean edged slit.The slit when viewed under magnification, penetrates both layers.The slit aligns on the layers and the fibers on the edges of the slit appear severed.Sample 2: there are folds and heavy creases on the sample.There are also indentations on the sample which appear to be outlines of instrument trays.There is one circled area on the blue layer.There is a hole that penetrates the blue layer only.There is no hole observed on the white layer in that same area.The hole was viewed under magnification.The fibers around the edges of the blue layer appear abraded, raised and lofty.The material of the hole appears torn and pushed outward.The same area was viewed on the white layer.No damage is observed on the white layer.The hole is only observed on the blue layer.Sample 3: there are folds and heavy creases on the sample.There are also indentations on the sample which appear to be outlines of instrument trays.There is one circled area on the blue layer.There is a hole that appears as an irregular slit that penetrates both layers.The slits align on the layers.The slit is located on the edge of an indentation.The area was viewed under magnification.The slit on the blue layer appears longer than when viewed on the white layer.The fibers on the edges of the slit appear severed.It is possible that the slit originated on the blue layer.The complaint details were forwarded to the appropriate functional area for investigation and root cause determination.The samples returned exhibited folds and heavy creases with holes noted in these areas of the wrap.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.According to dhr, the material met all specifications during inspections conducted during manufacture.No machine issues were documented which could contribute to the noted holes/cuts.Complaint metrics are reviewed by complaint review board monthly to identify any trends related to product complaints and identify any corrective action needs.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.

• Brand Name: KIMGUARD ONE-STEP QUICK CHECK STERILIZATION WRAP, KC 600
• 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 fritzgerald road; linwood NC 27299
• Manufacturer Contact: nichole early ; 1 edison drive; alpharetta, GA 30005 ; 8287820529
• MDR Report Key: 18727059
• Report Number: 1054380-2024-00001
• Device Sequence Number: 12320934
• Product Code: FRG
• UDI-Device Identifier: 30680651341472
• UDI-Public: 30680651341472
• 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): 04/08/2024

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: 991034147
• Device Lot Number: LT3338
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/24/2024
• 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: 01/18/2024
• Supplement Date Received by Manufacturer: 03/01/2024
• Initial Report FDA Received Date: 02/16/2024
• Supplement Report FDA Received Date: 04/08/2024
• 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): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown