MAUDE Adverse Event Report: MEDLINE INDUSTRIES LP; DBD-ORTHO MAJOR PACK

Model Number DYNJ40430D

Device Problem Contamination /Decontamination Problem (2895)

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

Event Date 04/10/2023

Event Type  malfunction  

Manufacturer Narrative

It was reported that a hair was in the bulb syringe.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.In an abundance of caution, and in response to an fda 483 issued for cfn (b)(4) 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 a hair was in the bulb syringe.

• Type of Device: DBD-ORTHO MAJOR PACK
• Manufacturer (Section D): MEDLINE INDUSTRIES LP; three lakes drive; northfield IL 60093 2753
• Manufacturer Contact: jeffrey de torres ; three lakes drive; northfield, IL 60093-2753
• MDR Report Key: 19085454
• MDR Text Key: 339990981
• Report Number: 1423395-2024-00253
• 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: 04/10/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/10/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: DYNJ40430D
• Device Lot Number: 23ABG106
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/17/2023
• Date Manufacturer Received: 04/10/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other