MAUDE Adverse Event Report: O&M HALYARD, INC. QUICK CHECK H400 STERILIZATION WRAP; 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	04/23/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
One sample was received with no product packaging received.There is sterilization indicator tape affixed to the surface of the blue layer.The sample was evaluated under ambient light conditions.The sample arrived with a circled area on the blue layer.In addition to sterilization indicator tape there are medical procedure labels affixed to the surface of the blue layer.The sample has creases and folds, and the circled area appears near or on one of the folds.The circled area exhibits damaged fibers and a hole.The damaged area including the hole measures approximately 6mm.The hole penetrated both layers and the holes align on the layers.The area was viewed under magnification.The hole on the blue layer appears irregular and the fibers appear abraded, lofty and raised.Due to the orientation of the fibers and the appearance of the hole, it is possible that the hole originated on the blue layer.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).
Event or Problem Description
There were holes in the wrap noted after sterilization.Surgical procedure was cancelled.This was a podiatry procedure.The customer stated that both the initial tray for use in the procedure and the backup tray exhibited holes.The issue was noticed prior to use with the patient; however, the procedure was delayed and cancelled for the day.The patient was transferred to another facility to complete the procedure.The hospital incurred the cost of the procedure.There was no injury reported.
Additional Manufacturer Narrative
One (1) used sample was received with no product packaging.The sample has creases and folds, and the circled area appears near or on one of the folds.The circled area exhibits damaged fibers and a hole.The damaged area including the hole measures approximately 6mm.The hole penetrates both layers.The holes align on the layers.A device history record evaluation was performed for the lot number reported.The products were manufactured according to approved manufacturing procedures and specifications.The complaint details were forwarded to the appropriate functional area for investigation and root cause determination.The manufacturing process requires two separate rolls, one blue and one white, to be brought together and bonded to form the quick check sterilization wrap.It would be unlikely for these two separate sheets to line up together and have an exact location of holes as these show.A root cause was not determined for the reported issue.This product incident is documented in the o&m halyard, inc.Complaint database and identified as complaint (b)(6).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 H400 STERILIZATION WRAP
• 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 rd; linwood NC 27299
• Manufacturer Contact: nichole early ; 1 edison drive; alpharetta, GA 30005 ; 8287820529
• MDR Report Key: 19415677
• Report Number: 1054380-2024-00004
• Device Sequence Number: 8507929
• Product Code: FRG
• UDI-Device Identifier: 30680651341458
• UDI-Public: 30680651341458
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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): 06/28/2024

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: 103414520
• Device Lot Number: LT4024000-1153
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/15/2024
• 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: 05/03/2024
• Supplement Date Received by Manufacturer: 06/17/2024
• Initial Report FDA Received Date: 05/29/2024
• Supplement Report FDA Received Date: 06/28/2024
• 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