MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP; DBD-ANGIO DRAPE CARDIAC PACK

Model Number DYNJ51615K

Device Problem Material Integrity Problem (2978)

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

Event Date 01/28/2021

Event Type  malfunction  

Manufacturer Narrative

It was reported that a control syringe component was cracked.Reportedly, the problem/issue was identified during set up for a procedure.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 photographed control syringe had an area that appeared melted and displaced from the main barrel of the component.The are that appeared melted was observed to have holes at what appeared to be at equal intervals around the control syringe.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.

Event Description

It was reported that a control syringe component was cracked.

• Type of Device: DBD-ANGIO DRAPE CARDIAC PACK
• 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: 18984527
• MDR Text Key: 338666927
• Report Number: 1423395-2024-00221
• Device Sequence Number: 1
• Product Code: OJG
• 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

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: DYNJ51615K
• Device Lot Number: 20EKA851
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/28/2021
• Initial Date FDA Received: 03/27/2024
• Was Device Evaluated by Manufacturer?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other