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	Fitting Problem (2183)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	06/20/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The product involved in the report has been returned and is being processed for evaluation.A review of the device history record is in-progress.Upon completion of the sample evaluation and investigation; a follow-up report will be filed.All information reasonably known as of 15apr2021 has been included in this health authority report.Should additional information be obtained, a follow-up health authority report will be provided.The information provided by o&m halyard, inc.Represents all of the known information at this time.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 halyard health complaint database and identified as complaint (b)(4).
Event or Problem Description
O&m halyard, inc.Received a single report that referenced two different incidences, which were associated with separate units, involving two different patients.This is the second of two reports.Refer to 3014421917-2021-00001 for the first patient.It was reported by the customer who stated, we are reaching out to you to inform you of an issue we are having using your arterial wrist support.We have had issues with them causing pressure sores between the thumb and fore finger.Additional information was received on 9-april-2021 that states, there ware two patients who have unstageable pressure injuries.No additional information has been received.
Additional Manufacturer Narrative
The product involved in the report has been processed for evaluation.The failure analysis lab (fal)received one (1) unused sample with no product packaging.The sample was evaluated under ambient light conditions.The sample and the ifu arrived inside its plastic bag and the sample appeared intact.The plastic bag was opened in the lab and the sample was inspected.The foam loop material was unwound from the wrist support.The two strips of loop material measure approximately 15 inches.The white arterial hand-aid starter block is inside the wrist support.The white foam block was removed.It reveals that the blue foam inside the wrist support appears indented with the shape of the white foam block.Also observed: the white foam block has an indentation on the side where it was secured inside the wrist support when wrapped with the loop material.The opposite ends of the loop material are affixed to the hook strip on the hard wrist support.They overlap each other.The fal is unable to evaluate the incident reported of the hook and loop being too aggressive with the evaluation performed in the lab.The device history record could not be reviewed as a lot number was not provided by the customer.An assessment of the production line was performed.The raw material foam was checked, the quality inspector at the external supplier was asked for the report of receipt and the certificate of conformity.The raw material was made according to the specification, the inspection receipt was accepted.A root cause was not identified since the raw material has not had any changes.No irregularities were found in the manufacturing process.All information reasonably known as of 08june2021 has been included in this health authority report.Should additional information be obtained, a follow-up health authority report will be provided.The information provided by o&m halyard, inc.Represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant/reporter was unable or unwilling to provide any further patient, product, or procedural details to o&m halyard, inc.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 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 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
• MDR Report Key: 11680326
• Report Number: 3014527898-2021-00002
• Device Sequence Number: 16917991
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/19/2021

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/12/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 03/24/2021
• Supplement Date Received by Manufacturer: 05/19/2021
• Initial Report FDA Received Date: 04/16/2021
• Supplement Report FDA Received Date: 06/08/2021
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other