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

Model Number EMZE010001

Device Problem Fluid/Blood Leak (1250)

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

Event Date 05/03/2019

Event Type  malfunction  

Event Description

It was reported that the pre-filled syringe "leaked" within its sealed wrapper.

Manufacturer Narrative

It was reported that the pre-filled syringe "leaked" within its sealed wrapper as moisture was noted within the overwrap.Reportedly, "the stopper and plunger" was intact.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.A sample was returned for evaluation.Moisture was observed to be present in the overwrap with no cracks, leaks, or leaking pistons noted on any of the returned samples.Retention samples were evaluated as well with no defects observed.It is believe that the reported syringes had residual moisture on them following sterilization that was carried into the syringe overwrap.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.If additional relevant information becomes available a supplemental medwatch will be filed.

• Type of Device: SYRINGE, 10ML SALINE IN 10ML
• Manufacturer (Section D): MEDLINE EXCELSIOR; 1933 heck drive; neptune NJ 07753 4428
• Manufacturer Contact: nigel vilches ; three lakes drive; northfield, IL 60093-2753
• MDR Report Key: 18954341
• MDR Text Key: 338334950
• Report Number: 2027791-2024-00024
• Device Sequence Number: 1
• Product Code: NGT
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/20/2024

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
• Device Model Number: EMZE010001
• Device Lot Number: 3135347
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/21/2019
• Initial Date Manufacturer Received: 05/03/2019
• Initial Date FDA Received: 03/21/2024
• Was Device Evaluated by Manufacturer?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other