MAUDE Adverse Event Report: MERIT MEDICAL SYSTEMS, INC. MERIT CUSTOM KIT; CATHETER, INTRAVASCULAR, DIAGNOSTIC

Catalog Number K12T-04870B

Device Problems Hole In Material (1293); Out-Of-Box Failure (2311); Tear, Rip or Hole in Device Packaging (2385); Contamination /Decontamination Problem (2895)

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

Event Date 04/08/2014

Event Type  malfunction  

Event Description

The user reported there is a small hole in the clear film material of the package causing a breach in the sterile barrier.This was discovered at prep and the kit was not used on pt.

Manufacturer Narrative

Device eval: the device is not expected to return for eval.A f/u report will be submitted when the eval has been completed.

Manufacturer Narrative

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.Merit is unable to determine a root cause without the returned device.

• Brand Name: MERIT CUSTOM KIT
• Type of Device: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): MERIT MEDICAL SYSTEMS, INC.; south jordan UT
• Manufacturer Contact: jerry mcphine ; 1600 west merit pkwy; south jordan, UT 84095 ; 8012084491
• MDR Report Key: 3944072
• MDR Text Key: 4603506
• Report Number: 1125782-2014-00004
• Device Sequence Number: 1
• Product Code: DQO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K913682
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative,company representative
• Reporter Occupation: Not Applicable
• Type of Report: Initial,Followup
• Report Date: 04/08/2014

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: 08/31/2016
• Device Catalogue Number: K12T-04870B
• Device Lot Number: T578172
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/08/2014
• Initial Date FDA Received: 05/01/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/04/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/01/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1