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

Model Number EMZE010001

Device Problem Contamination (1120)

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

Event Date 04/27/2020

Event Type  malfunction  

Event Description

It was reported that foreign particulate was identified within the saline flush.

Manufacturer Narrative

It was reported that foreign particulate, which the reporting facility described as blood, was identified to be floating within the saline flush prior to being used on a patient.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.Pictures of the substance were provided to the manufacturer which confirmed a red foreign matter.A sample was returned for evaluation and it was confirmed that a fiber was present within the fluid pathway; however, there was no red color or an indication that blood was present as indicated in pictures from the reporting facility.Batch records were reviewed and no issues were identified which could have caused the reported foreign matter contamination.Additionally, all inspection records performed on the reported lot were reviewed and no instances of foreign matter or discoloration were identified.A root cause investigation was performed and it was determined that the foreign matter most likely originated at the reporting facility at the time of use.Due to the reported foreign particulate contamination within the syringe fluid pathway, and in an abundance of caution, this medwatch is being filed.If additional relevant information because available, a supplemental medwatch will be filed.

• Type of Device: SYRINGE, 10ML SALINE IN 10ML
• Manufacturer (Section D): MEDLINE EXCELSIOR; 1933 heck avenue; neptune NJ 07753 4428
• Manufacturer Contact: nigel vilches ; three lakes drive; northfield, IL 60093-2753
• MDR Report Key: 18730256
• MDR Text Key: 336747173
• Report Number: 2027791-2024-00002
• 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: 02/19/2024

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: 3137388
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/27/2020
• Initial Date Manufacturer Received: 04/27/2020
• Initial Date FDA Received: 02/19/2024
• Was Device Evaluated by Manufacturer?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other