MAUDE Adverse Event Report: MEDLINE INDUSTRIES INC.; DBD-MAJOR HEAD AND NECK PACK-LF

Model Number DYNJ62821A

Device Problem Material Fragmentation (1261)

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

Event Date 06/03/2020

Event Type  malfunction  

Manufacturer Narrative

It was reported that the surgical pack was noted to have a broken syringe component.To date, no information has been received to indicate that a user or a patient experienced a death, serious injury, medical intervention, follow-up care, or other adverse health impact associated with the reported problem/issue.A photo was provided for review and the base of the syringe component's plunger was observed to have broken off.No physical sample was returned for evaluation.It was unable to be confirmed when the syringe component may have been damaged, however, it may have been prior to placement in the surgical pack.In an abundance of caution, and in response to an fda 483 issued for cfn 1417592 on 22-jan-2024, this medwatch is being filed for the reported problem/issue.If additional relevant information becomes available a supplemental medwatch will be filed.

Event Description

It was reported that the surgical pack was noted to have a broken syringe component.

• Type of Device: DBD-MAJOR HEAD AND NECK PACK-LF
• Manufacturer (Section D): MEDLINE INDUSTRIES INC.; three lakes drive; northfield IL 60093 2753
• Manufacturer Contact: nigel vilches ; three lakes drive; northfield, IL 60093-2753
• MDR Report Key: 18826349
• MDR Text Key: 337689061
• Report Number: 1423395-2024-00088
• Device Sequence Number: 1
• Product Code: OGR
• 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: 03/02/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/04/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: DYNJ62821A
• Device Lot Number: 20ABR182
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/03/2020
• Was Device Evaluated by Manufacturer?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other