MAUDE Adverse Event Report: O&M HALYARD, INC. STERILIZATION TRAY LINER TOWEL; STERILIZATION ACCESSORIES

Model Number	48139
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/18/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
***correction**** this emdr was originally reported under the incorrect mfr report number 9680646-2023-00001 on 06jun2023.The product involved in the event was returned and is being evaluated.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.
Event or Problem Description
The customer noticed light brown staining on the halyard 48139 tray liners.This incident occurred several times consistently for a few days at the hospital and caused them to stop sterilizing trays for a period of time.No patients were injured; however, surgery delayed.
Additional Manufacturer Narrative
Received two (2) used samples with no product packaging.The samples were evaluated under ambient light conditions.Both samples arrived loosely folded.Both samples exhibit handwritten notes.Both samples were laid out on the lab table.Both samples appear wrinkled.Evaluation samples as follows: sample 1 exhibits several areas that appear to have what can be described as yellowish-brown stains.The stains appear in the creases where the sheet would have been originally folded.Additionally, there are stains in other areas where there are no folds or creases.Except for where there are folded creases, the stains are not observed on the reverse side of the sample.Two representative areas of stains were viewed under magnification.The yellowish-brown stains appear embedded into the fibers of the sheet.Sample 2 exhibits several areas that appear to have what can be described as yellowish-brown stains.The stains appear in wrinkled areas of the sheet.The stains are not observed on the reverse side of the sample.Two representative areas of stains were viewed under magnification.The yellowish-brown stains appear embedded into the fibers of the sheet.The complaint details were forwarded to the appropriate functional area for investigation and root cause determination.Based on the results of the investigation we could confirm the failure reported.A root cause could not be identified.Conditions that must be considered are the method of sterilization and chemical or substances used during the sterilization process performed by the end-user.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: STERILIZATION TRAY LINER TOWEL
• Common Device Name: STERILIZATION ACCESSORIES
• Manufacturer (Section D): O&M HALYARD, INC.; 1 edison drive; alpharetta GA 30005
• Manufacturer (Section G): LA ADA DE ACUNA, S. DE. R. L. DE C. V.; av. hidalgo no. 6 esq; blvd. luis donaldo colosio; col.educativa, nogales sonora 84093 ; MX 84093
• Manufacturer Contact: nichole early ; 1 edison drive; alpharetta, GA 30005 ; 8287820529
• MDR Report Key: 17140411
• Report Number: 3005997949-2023-00003
• Device Sequence Number: 19315659
• Product Code: PUI
• UDI-Device Identifier: 30680651481390
• UDI-Public: 30680651481390
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• 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): 08/01/2023

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: 48139
• Device Catalogue Number: 48139
• Device Lot Number: AC22348031
• Was Device Available for Evaluation?: Yes
• 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: 05/18/2023
• Supplement Date Received by Manufacturer: 07/13/2023
• Initial Report FDA Received Date: 06/15/2023
• Supplement Report FDA Received Date: 08/02/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown