MAUDE Adverse Event Report: MEDLINE INDUSTRIES INC. MEDLINE INDUSTRIES, INC.; DBD-EP FEMORAL PACK SAFETY 1

Model Number	DYNJ54701B
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/30/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Email received by vanderbilt university medical center, with additional information related to this incident.It was reported, "the tip of a syringe broke off and got stuck inside the lumen of a pigtail catheter." reporter confirms the incident occurred (b)(6) 2020.Reporter states, "the pigtail catheter was removed and a new one was replaced.The patient was under general anesthesia, no more medication was needed." reporting facility has indicated that the syringe, pigtail, and lot number of the pack are all available for return and evaluation.Currently awaiting investigation results.No further information.Due to the reported incident, medical intervention and 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.
Event or Problem Description
It was reported, "the tip of a syringe broke off and got stuck inside the lumen of a pigtail catheter.".

• Brand Name: MEDLINE INDUSTRIES, INC.
• Common Device Name: DBD-EP FEMORAL PACK SAFETY 1
• Manufacturer (Section D): MEDLINE INDUSTRIES INC.; three lakes drive; northfield IL 60093
• MDR Report Key: 11028986
• Report Number: 1423395-2020-00037
• Device Sequence Number: 11021485
• Product Code: OGR
• UDI-Device Identifier: 10193489222685
• UDI-Public: 10193489222685
• 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: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 12/17/2020

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
• Operator of Device: Health Professional
• Device Model Number: DYNJ54701B
• Device Catalogue Number: DYNJ54701B
• Device Lot Number: 20EBV379
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/01/2020
• Initial Report FDA Received Date: 12/17/2020
• 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: Required Intervention