MAUDE Adverse Event Report: MERIT MEDICAL SYSTEMS, INC. STERILIZED CONVENIENCE KIT

Catalog Number PC101

Device Problem Delivered as Unsterile Product (1421)

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

Event Date 11/25/2015

Event Type  malfunction  

Manufacturer Narrative

Device evaluation.One device returned for evaluation.The evaluation is in-process.A follow up report will be submitted when the evaluation has been completed.

Event Description

The distributor reported a defect in the packaging.This was identified during their initial inspection of received product.The device was not sent to a user facility.

Manufacturer Narrative

One device was received for evaluation.The inspection identified the package was sealed at an angle.No breach in the sterile barrier was identified.The complaint was confirmed, however the defect did not affect the sterility of the device.The root cause of the defect was a manufacturing deficiency.The device history record was reviewed and no exception documents were found.The complaint database was reviewed and no similar complaints for this lot number were found.

Manufacturer Narrative

During a routine internal audit it was found that the device manufacture date on the initial mdr was incorrect.The manufacture date has been corrected in this report.

• Brand Name: STERILIZED CONVENIENCE KIT
• Type of Device: STERILIZED CONVENIENCE KIT
• Manufacturer (Section D): MERIT MEDICAL SYSTEMS, INC.; 12701 kingston ave; chester VA 23836
• Manufacturer (Section G): MERIT MEDICAL SYSTEMS, INC.; 12701 kingston ave; chester VA 23836
• Manufacturer Contact: jerry mcphie ; 1600 west merit parkway; south jordan 84095 ; 8012084491
• MDR Report Key: 5305118
• MDR Text Key: 33703655
• Report Number: 1125782-2015-00037
• Device Sequence Number: 1
• Product Code: KDD
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: EXEMPT
• 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,Followup
• Report Date: 11/25/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/16/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2018
• Device Catalogue Number: PC101
• Device Lot Number: T819882
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/09/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/23/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/28/2015
• 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