MAUDE Adverse Event Report: MERIT MEDICAL SYSTEMS, INC MERIT CUSTOM KIT

Catalog Number K08-MP5159A

Device Problems Device Packaging Compromised (2916); Packaging Problem (3007)

Patient Problem No Patient Involvement (2645)

Event Date 09/09/2016

Event Type  malfunction  

Manufacturer Narrative

The distributor returned 119 units for evaluation.A sample of units were examined visually.The complaint is confirmed.The root cause is attributed to the manufacturing process.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.Corrective actions are in process for this failure mode.Merit determined on (b)(6) 2016 that a product removal would be required for four lots of kits affected by this packaging defect.Communications to consignees began on (b)(6) 2016.A report to the fda in accordance with 21 cfr 806.10 is in process and will be sent within the ten day requirement of initiating field action.No additional 3500a forms will be filed for this event.

Event Description

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

• Brand Name: MERIT CUSTOM KIT
• Type of Device: CUSTOM KIT
• Manufacturer (Section D): MERIT MEDICAL SYSTEMS, INC; 1600 west merit parkway; south jordan UT 84095
• Manufacturer (Section G): MERIT MEDICAL SYSTEMS, INC; 1600 west merit parkway; south jordan UT 84095
• Manufacturer Contact: casey hughes, ms, cqe ; 1600 west merit parkway; south jordan, UT 84095 ; 8013164932
• MDR Report Key: 5980490
• MDR Text Key: 55739452
• Report Number: 1721504-2016-00189
• Device Sequence Number: 1
• Product Code: DQO
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K913682
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 09/09/2016

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 Expiration Date: 07/31/2019
• Device Catalogue Number: K08-MP5159A
• Device Lot Number: H996433
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/19/2016
• Initial Date Manufacturer Received: 09/09/2016
• Initial Date FDA Received: 09/27/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/12/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Removal/Correction Number: 1721504-09/22/16-005R
• Patient Sequence Number: 1