MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP Medline Industries, Inc.; RAPID ECMO RESPONSE KIT-LF

Model Number	DYNJ51449C
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/10/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Piece fell off into the patient.
Additional Manufacturer Narrative
According to the customer, "the piece attached to the syringe fell off and into the patient and had to be dug out during the procedure".The customer reports "prolonged anesthesia" due to the incident but the procedure was completed.No injury or additional medical intervention was reported.No additional details were provided by the customer.A sample has been requested but is not available to be returned for evaluation.A root cause has not been established at this time.It has been determined that the reported event could cause or contribute to serious injury if it were to occur again.In an abundance of caution this medwatch is being filed.If any further relevant information is identified or obtained, a supplemental medwatch will be submitted.

• Brand Name: Medline Industries, Inc.
• Common Device Name: RAPID ECMO RESPONSE KIT-LF
• Manufacturer (Section D): MEDLINE INDUSTRIES, LP; three lakes drive; northfield IL 60093
• Manufacturer Contact: kelly zampella ; three lakes drive; northfield, IL 60093
• MDR Report Key: 16479721
• Report Number: 1423395-2023-00009
• Device Sequence Number: 3150845
• Product Code: LRO
• UDI-Device Identifier: 10193489470840
• UDI-Public: 10193489470840
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/03/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: DYNJ51449C
• Device Catalogue Number: DYNJ51449C
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/10/2023
• Initial Report FDA Received Date: 03/03/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown