MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP; DBD-HEART CATH

Model Number DYNJ43470J

Device Problems Crack (1135); Fluid/Blood Leak (1250)

Patient Problem Exposure to Body Fluids (1745)

Event Date 08/23/2023

Event Type  malfunction  

Event Description

It was reported that the pack was received with a cracked syringe component.

Manufacturer Narrative

It was reported that the pack was received with a cracked syringe component.Reportedly, component use resulted in blood being sprayed onto a surgeon.A new syringe was reportedly obtained and no further incident was reported.No serious injury or adverse impact to a patient or a user was originally reported.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 and the syringe was observed to have a long straight crack.The root cause was determined to be mishandling of the product where the item was either damaged prior to placement in the pack and was not noted during assembly or the item became damaged due to rough handling of the 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.

• Type of Device: DBD-HEART CATH
• 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: 18980714
• MDR Text Key: 338670393
• Report Number: 1423395-2024-00210
• Device Sequence Number: 1
• Product Code: OES
• UDI-Device Identifier: 40195327377855
• UDI-Public: 40195327377855
• 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: 03/26/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/26/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: DYNJ43470J
• Device Lot Number: 23EMB312
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/06/2023
• Date Manufacturer Received: 08/25/2023
• 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