MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP; DBD-DR SOMERS OPEN HEART CHRG

Model Number DYNJ905748

Device Problem Material Separation (1562)

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

Event Date 08/05/2019

Event Type  malfunction  

Manufacturer Narrative

It was reported that the plunger separated from the barrel of a syringe component.Reportedly, this occurred intra-operative vein harvesting and that the patency check of the harvested vein was interrupted.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 sample was returned for evaluation.Visual inspection of the sample identified no damage.Upon functional examination it was noted that the plunger was harder to retract from the barrel of the syringe, and once it got near the top of the barrel the black rubber section of the plunger fell off of the plunger.The root cause was determined to be a vendor-related issue.Due to the reported problem/issue, and in an abundance of caution, this medwatch is being filed.If additional relevant information becomes available a supplemental medwatch will be filed.

Event Description

It was reported that the plunger separated from the barrel of a syringe component.

• Type of Device: DBD-DR SOMERS OPEN HEART CHRG
• Manufacturer (Section D): MEDLINE INDUSTRIES, LP; three lakes drive; northfield IL 60093 2753
• Manufacturer Contact: nigel vilches ; three lakes drive; northfield, IL 60093-2753
• MDR Report Key: 18784738
• MDR Text Key: 337253798
• Report Number: 1423395-2024-00060
• Device Sequence Number: 1
• Product Code: OEZ
• 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: 02/26/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/26/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: DYNJ905748
• Device Lot Number: 19FDC127
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/07/2019
• Date Manufacturer Received: 08/05/2019
• Was Device Evaluated by Manufacturer?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other