MAUDE Adverse Event Report: O&M HALYARD, INC. HAND-AID* ARTERIAL WRIST SUPPORT; PATIENT CARE IV THERAPY SUPPORT PRODUCT

Model Number	29980
Medical Device Problem Code	Pressure Problem (3012)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	01/13/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Patient # two.It was initially reported by complainant that there was a pressure injury that occurred in the icu in (b)(6) as a result of arterial stabilization device.Complainant provided additional information stating there were two incidents.Event dates were: (b)(6) 2023 and the number of patients were two.Patient 2: the patient has been discharged.The device was removed and/or was replaced with different foam arterial device.The location of the injury was the left hand inner palm.The type of injury was a deep tissue pressure wound.The procedure an arterial line stabilization applied in the emergency room (er).The patient was sent to the intensive care unit with the device in place from er.
Additional Manufacturer Narrative
Patient # 2 the product involved in the event was not available for return.A follow-up report will be provided upon conclusion of investigation.All information reasonably known as of (b)(6) 2023 has been included in this medical device report.O&m halyard, inc.Has no independent knowledge of the event reported but is relaying the information that was provided by the user facility where the incident occurred.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 21 cfr 803, 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
Patient # 2.The sample was evaluated under ambient light conditions.The sample arrived inside a torn plastic product package.The plastic package was opened, and the sample was removed for inspection.The sample appears intact.The foam straps are wrapped as in the original state.The foam straps were carefully unwrapped.The foam straps appear intact.The sample does not exhibit any discoloration on the foam straps or on the foam pad.There are no sharp edges or damages observed on the wrist support.There are no damaged areas observed on the sample.The falure analysis lab is unable to evaluate the reaction experienced by the customer with the evaluation conducted in the lab.The manufacturer provided an investigation response indicating leaders, operators and the production coordinator were informed of complaint.The complaint lot production records were reviewed and inspection results were found to be within product specification.The manufacturer indicated no other complaints have been received within the prior 12 months.The manufacturer reviewed the injury photos and suggested that if the foam strip was tied too tight this may result in the observed pressure wound.Complaint has been logged 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.

• Common Device Name: PATIENT CARE IV THERAPY SUPPORT PRODUCT
• Manufacturer (Section D): O&M HALYARD, INC.; 1 edison drive; alpharetta GA 30005
• Manufacturer (Section G): BOSS (BORDER OPPORTUNITY SAVER SYSTEMS; 10 finegan drive; del rio TX 78841 1407
• Manufacturer Contact: nichole early ; 1 edison drive; alpharetta, GA 30005 ; 8287820529
• MDR Report Key: 16700950
• Report Number: 3014421917-2023-00003
• Device Sequence Number: 12179975
• Product Code: ILH
• UDI-Device Identifier: 30680651299803
• UDI-Public: 30680651299803
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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): 09/29/2023

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: 29980
• Device Catalogue Number: 102998080
• Device Lot Number: UNKNOWN
• 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: 03/09/2023
• Supplement Date Received by Manufacturer: 09/13/2023
• Initial Report FDA Received Date: 04/07/2023
• Supplement Report FDA Received Date: 10/03/2023
• 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: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 50 YR
• Patient Sex: Female
• Patient Weight: 77 KG
• Patient Race: White