MAUDE Adverse Event Report: MEDLINE INDUSTRIES LP; SOFT/NEURO PACK-LF

Catalog Number DYNJ35195C

Device Problem Device Misassembled During Manufacturing /Shipping (2912)

Patient Problem Insufficient Information (4580)

Event Date 07/19/2022

Event Type  malfunction  

Manufacturer Narrative

A defective bulb syringe was reported.To date, no information has been received to indicate that a user or a patient experienced a death, serious injury, medical intervention, follow-up care, or other adverse health impact associated with the reported problem/issue.In an abundance of caution, and in response to an fda 483 issued for cfn 1417592 on 22-jan-2024, this medwatch is being filed for the reported problem/issue.If additional relevant information becomes available a supplemental medwatch will be filed.

Event Description

Defective bulb syringe.

• Type of Device: SOFT/NEURO PACK-LF
• Manufacturer (Section D): MEDLINE INDUSTRIES LP; three lakes drive; northfield IL 60093
• Manufacturer Contact: kelly zampella ; three lakes drive; northfield, IL 60093
• MDR Report Key: 18949321
• MDR Text Key: 338241872
• Report Number: 1423395-2024-00168
• Device Sequence Number: 1
• Product Code: OJG
• UDI-Device Identifier: 40888277090911
• UDI-Public: 40888277090911
• 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: 03/21/2024

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 Catalogue Number: DYNJ35195C
• Device Lot Number: 22EMF280
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/08/2022
• Initial Date Manufacturer Received: 07/19/2022
• Initial Date FDA Received: 03/21/2024
• 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