MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP; DBD-EP FEMORAL PACK SAFETY 1

Model Number DYNJ54701B

Device Problems Break (1069); Material Fragmentation (1261)

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

Event Date 09/29/2020

Event Type  malfunction  

Event Description

It was reported that the tip of syringe component broke off while flushing a pigtail catheter.

Manufacturer Narrative

It was reported that the tip of syringe component broke off while flushing a pigtail catheter.Reportedly, the syringe tip became lodged in the catheter part.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 received for review and the reported problem/issue was confirmed.No physical sample was returned for evaluation.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.

• Type of Device: DBD-EP FEMORAL PACK SAFETY 1
• 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: 18921560
• MDR Text Key: 337871105
• Report Number: 1423395-2024-00148
• Device Sequence Number: 1
• Product Code: OGR
• UDI-Device Identifier: 40193489222686
• UDI-Public: 40193489222686
• 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: 03/15/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/18/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: DYNJ54701B
• Device Lot Number: 20EBQ985
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/29/2020
• Was Device Evaluated by Manufacturer?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other