MAUDE Adverse Event Report: MERIT MEDICAL SYSTEMS, INC. MEDALLION SYRINGE

Catalog Number MSS121P

Device Problem Contamination /Decontamination Problem (2895)

Patient Problem No Patient Involvement (2645)

Event Date 11/15/2019

Event Type  malfunction  

Manufacturer Narrative

Device was returned for evaluation.The device was examined visually and the complaint was confirmed.The root cause was undetermined.The device history record was reviewed and no exception documents were found.The complaint database was reviewed and no similar complaints were found for this lot number.

Manufacturer Narrative

The suspect device has been returned for evaluation.A follow up will be submitted when the evaluation is complete.

Event Description

The account alleges that there is a contamination on the syringe barrel.There is no harm to patients.

• Brand Name: MEDALLION SYRINGE
• Type of Device: SYRINGE
• Manufacturer (Section D): MERIT MEDICAL SYSTEMS, INC.; 1600 merit parkway; south jordan UT 84095
• Manufacturer (Section G): MERIT MEDICAL SYSTEMS, INC.; 1600 merit parkway; south jordan UT 84095
• Manufacturer Contact: david lockridge ; 1600 merit parkway; south jordan, UT 84095 ; 8012084551
• MDR Report Key: 9501112
• MDR Text Key: 183020311
• Report Number: 1721504-2019-00106
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K875196
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2023
• Device Catalogue Number: MSS121P
• Device Lot Number: H1671214
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/03/2019
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/20/2019
• 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