MAUDE Adverse Event Report: MEDLINE INDUSTRIES INC.; NEURO HBO 85949

Catalog Number DYNJ30469I

Device Problem Material Separation (1562)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/08/2020

Event Type  malfunction  

Manufacturer Narrative

It was reported that a patient was undergoing spinal surgery and during the case part of the blue x-ray detectable material broke off of the gauze and needed to be retrieved from the patients surgical sie.The issue was noted mid procedure.The material was able to be removed with an instrument and the procedure continued without further incident.There was no impact to the patient or the procedure being performed.The patient was under anesthesia; however no additional anesthesia or medication was required.There was no report of any adverse patient consequence and no effect on the patient's stability as a result of the incident.There were no complications noted with the patient during or after the procedure.The actual sample was not returned to the manufacturer for evaluation and no root cause could be determined.No additional information is available.Due to the reported incident, this medwatch is being filed.If additional relevant information becomes available a supplemental medwatch will be filed.

Event Description

The x-ray detectable material from the gauze sponge fell apart during a procedure and a piece fell into the surgical site requiring manual removal.

• Type of Device: NEURO HBO 85949
• Manufacturer (Section D): MEDLINE INDUSTRIES INC.; three lakes drive; northfield IL 60093 2753
• Manufacturer Contact: karen trutsch ; three lakes drive; northfield, IL 60093-2753
• MDR Report Key: 10626297
• MDR Text Key: 209782933
• Report Number: 1423395-2020-00029
• Device Sequence Number: 1
• Product Code: OJH
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/05/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: DYNJ30469I
• Device Lot Number: 20BBV692
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/10/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 69 YR
• Patient Weight: 70