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

Model Number	DYNJ51615N
Medical Device Problem Codes	Break (1069); Crack (1135)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/05/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was reported that a control syringe component was found to be "broken and cracked" within the pack.No serious injury or adverse impact to a procedure, patient, or 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 sample was observed to have a damaged barrel and a cracked plunger.The reported problem/issue was confirmed.A definitive root cause was unable to be determined, however, potential root causes include component damage prior to pack placement that was not noted during assembly or damage 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.
Event or Problem Description
It was reported that a control syringe component was found to be "broken and cracked" within the pack.

• Common Device Name: 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: 19060395
• Report Number: 1423395-2024-00338
• Device Sequence Number: 20298456
• Product Code: OES
• UDI-Device Identifier: 40195327418947
• UDI-Public: 40195327418947
• Combination Product (Y/N): N
• Initial Reporter State: HI
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/08/2024

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: DYNJ51615N
• Device Lot Number: 23FMB975
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/17/2023
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/05/2023
• Initial Report FDA Received Date: 04/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown