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

Catalog Number DYNJV0072Q

Device Problems Material Fragmentation (1261); Device Fell (4014)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/29/2020

Event Type  malfunction  

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 Description

It was reported, "a flake of the bulb syringe came off and fell into the patient.".

• Type of Device: DBD-SPINAL SURGERY PACK
• Manufacturer (Section D): MEDLINE INDUSTRIES, INC.; three lakes drive; northfield IL 60093
• Manufacturer Contact: teresa maynard ; three lakes drive; northfield, IL 60093 ; 2249311514
• MDR Report Key: 11209201
• MDR Text Key: 258429094
• Report Number: 1423395-2021-00002
• Device Sequence Number: 1
• Product Code: OJH
• UDI-Device Identifier: 10193489274059
• UDI-Public: 10193489274059
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/21/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/08/2021
• Was Device Evaluated by Manufacturer?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention