MAUDE Adverse Event Report: MEDLINE INDUSTRIES, INC.; DBD-SPINAL SURGERY PACK

Catalog Number	DYNJV0072Q
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/29/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Email received by perioperative business coordinator, (b)(6) hospital with additional information in regards to this complaint.Reporter states, incident occurred (b)(6) 2020.Reporter states, "flake of the bulb syringe in the pack came off and fell into the patient.The fragment was removed from the patient and the bulb syringe was removed from the surgical field.This did not result in any known damage or injury to the patient." sample is available for return and evaluation.No further information has been provided.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, "a flake of the bulb syringe came off and fell into the patient.".

• Common Device Name: DBD-SPINAL SURGERY PACK
• Manufacturer (Section D): MEDLINE INDUSTRIES, INC.; three lakes drive; northfield IL 60093
• MDR Report Key: 11209201
• Report Number: 1423395-2021-00002
• Device Sequence Number: 3582658
• Product Code: OJH
• UDI-Device Identifier: 10193489274059
• UDI-Public: 10193489274059
• Combination Product (Y/N): N
• Initial Reporter State: OR
• 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): 01/21/2021

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 Catalogue Number: DYNJV0072Q
• Device Lot Number: 20HMC987
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/13/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/08/2021
• Initial Report FDA Received Date: 01/21/2021
• 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