MAUDE Adverse Event Report: MEDLINE INDUSTRIES LP; NEURO PACK

Catalog Number DYNJ48263G

Device Problem Device Contamination with Chemical or Other Material (2944)

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

Event Date 03/28/2024

Event Type  malfunction  

Manufacturer Narrative

According to the customer, on (b)(6) 2024 particulate was noted to be inside the syringe while drawing up "saline and contrast" into the bd syringe.The customer reported the particulate was present prior to drawing up the fluids.The customer reported there was no patient involvement, and the product was not used on the patient.The customer reported there was no serious injury, medical intervention, or follow up care required as a result of 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.

Event Description

According to the customer, on (b)(6) 2024 particulate was noted to be inside the syringe while drawing up "saline and contrast" into the bd syringe.

• Type of Device: NEURO PACK
• Manufacturer (Section D): MEDLINE INDUSTRIES LP; three lakes drive; northfield IL 60093
• Manufacturer Contact: danielle tognocchi ; three lakes dr; northfield, IL 60093
• MDR Report Key: 19218507
• MDR Text Key: 341745778
• Report Number: 1423395-2024-00407
• Device Sequence Number: 1
• Product Code: OJG
• UDI-Device Identifier: 40195327214143
• UDI-Public: 40195327214143
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/30/2024

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
• Device Operator: Health Professional
• Device Catalogue Number: DYNJ48263G
• Device Lot Number: 23LBV306
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/11/2024
• Initial Date Manufacturer Received: 04/02/2024
• Initial Date FDA Received: 04/30/2024
• Was Device Evaluated by Manufacturer?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other