MAUDE Adverse Event Report: MERIT MEDICAL SYSTEMS INC. SYRINGE.MEDALLION®.20 ML; SYRINGE, PISTON

Catalog Number MSS121-RE

Device Problem Material Puncture/Hole (1504)

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

Event Date 06/23/2022

Event Type  malfunction  

Manufacturer Narrative

The suspect device was returned for investigation.The device was examined visually and microscopically.Bubble testing per stp0171 confirmed a breach in the package.The root cause is attributed to the manufacturing process.The device history record was reviewed, and no exception documents were found.A search of the complaint database was performed and no similar complaints for this lot number were identified.

Event Description

The distributor alleges that there was a defect in the packaging seal resulting in incomplete sterilization of the contents.This was identified during an initial inspection of received product.The device was not sent to a user facility.No patient contact.

• Brand Name: SYRINGE.MEDALLION®.20 ML
• Type of Device: SYRINGE, PISTON
• 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: bryson heaton bsn,rn. ; 1600 merit parkway; south jordan, UT 84095
• MDR Report Key: 15199258
• MDR Text Key: 305056822
• Report Number: 1721504-2022-00072
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 00884450071335
• UDI-Public: 884450071335
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K173601
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative,Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/21/2022

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 Operator: Health Professional
• Device Catalogue Number: MSS121-RE
• Device Lot Number: H2420054
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/28/2022
• Initial Date Manufacturer Received: 07/28/2022
• Initial Date FDA Received: 08/10/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/27/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1