MAUDE Adverse Event Report: MERIT MEDICAL SYSTEMS INC. MERIT CUSTOM MANIFOLD

Model Number 193127

Device Problem Tear, Rip or Hole in Device Packaging (2385)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/06/2020

Event Type  malfunction  

Manufacturer Narrative

The suspect device has been returned for evaluation.The complaint is confirmed.The root cause is attributed to rough handling through shipping and handling.A search of the complaint database was performed and no similar complaints for this lot number were found.The device history record was reviewed and no exception documents were found.

Event Description

The account reported a defect in the packaging.This was identified during their initial inspection of the received product.The device was not used.No patient contact.

• Brand Name: MERIT CUSTOM MANIFOLD
• Type of Device: MANIFOLD
• Manufacturer (Section D): MERIT MEDICAL SYSTEMS INC.; 1600 merit parkway; south jordan,, ut
• Manufacturer (Section G): MERIT MEDICAL SYSTEMS INC.; 1600 merit parkway; south jordan,, ut
• Manufacturer Contact: david lockridge ; 1600 merit parkway; south jordan, ut ; 2084551
• MDR Report Key: 10174624
• MDR Text Key: 195787414
• Report Number: 1721504-2020-00046
• Device Sequence Number: 1
• Product Code: DQO
• UDI-Device Identifier: 00886333207060
• UDI-Public: 00886333207060
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/19/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/20/2023
• Device Model Number: 193127
• Device Catalogue Number: 503HN-R/CN
• Device Lot Number: H1757596
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/26/2020
• Date Manufacturer Received: 06/07/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/05/2020
• 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