MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP; EP PACK

Catalog Number	DYNJ45180B
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	04/25/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
According to the customer, the patient's "pacemaker pocked was open" and the doctor was doing "pick ups to dab the blood", when a "small piece of the string in the raytek came loose".
Additional Manufacturer Narrative
According to the customer, the patient's "pacemaker pocked was open" and the doctor was doing "pick ups to dab the blood", when a "small piece of the string in the raytek came loose".The customer reported the doctor took care of the reported issue "immediately" and "pulled it".The customer reported there were "no negative consequences" and the patient had a "normal recovery".The customer reported there was no serious injury, medical intervention, or follow-up care needed related to the reported incident.No additional information is available 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.

• Common Device Name: EP PACK
• Manufacturer (Section D): MEDLINE INDUSTRIES, LP; three lakes dr; northfield IL 60093 2753
• Manufacturer Contact: danielle tognocchi ; three lakes dr; northfield, IL 60093-2753
• MDR Report Key: 19383064
• Report Number: 1423395-2024-00415
• Device Sequence Number: 17093303
• Product Code: OES
• UDI-Device Identifier: 40195327439140
• UDI-Public: 40195327439140
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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): 05/23/2024

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
• Operator of Device: Health Professional
• Device Catalogue Number: DYNJ45180B
• Device Lot Number: 24BBK685
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/25/2024
• Initial Report FDA Received Date: 05/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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