MAUDE Adverse Event Report: MEDLINE INDUSTRIES LP; SYRINGE, 10ML SALINE IN 10ML

Catalog Number EMZ111240

Device Problems Structural Problem (2506); Difficult to Open or Remove Packaging Material (2922)

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

Event Date 03/07/2024

Event Type  malfunction  

Manufacturer Narrative

According to the customer, the flush syringes are "are cumbersome to use, difficult to open, and the glide when flushing often sticks" causing the nurses to "frequently contaminate them and have to get new ones".There was no report of serious injury or medical intervention/attention related to the reported incident.No additional details are available related to the customer reported issue.Despite multiple good faith efforts to obtain additional information, the customer contact was unable or unwilling to provide further incident details to the manufacturer.No additional information is available.Due to the reported problem/issue 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

According to the customer, the flush syringes are "are cumbersome to use, difficult to open, and the glide when flushing often sticks" causing the nurses to "frequently contaminate them and have to get new ones".

• Type of Device: SYRINGE, 10ML SALINE IN 10ML
• 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: 19047337
• MDR Text Key: 340113724
• Report Number: 2027791-2024-00066
• Device Sequence Number: 1
• Product Code: NGT
• UDI-Device Identifier: 10363807000039
• UDI-Public: 10363807000039
• 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: 04/04/2024

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: EMZ111240
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 03/07/2024
• Initial Date FDA Received: 04/04/2024
• 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): Other