MAUDE Adverse Event Report: MERIT MEDICAL SYSTEMS, INC. PRESSURE INFUSION BAG; INFUSOR, PRESSURE, FOR I.V. BAGS

Catalog Number PIB1000

Device Problems Air Leak (1008); Loss of or Failure to Bond (1068)

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

Event Date 12/14/2014

Event Type  malfunction  

Event Description

The user reported that the pressure infusion bag failed to maintain pressure.No harm or injury to the patient was reported.

Manufacturer Narrative

The device has not been returned for evaluation.A follow up report will be submitted when the evaluation has been completed.

• Brand Name: PRESSURE INFUSION BAG
• Type of Device: INFUSOR, PRESSURE, FOR I.V. BAGS
• Manufacturer (Section D): MERIT MEDICAL SYSTEMS, INC.; south jordan UT
• Manufacturer Contact: jerry mcphie ; 1600 west merit parkway; south jordan, UT 84095 ; 8012084491
• MDR Report Key: 4412644
• MDR Text Key: 5275257
• Report Number: 1721504-2015-00002
• Device Sequence Number: 1
• Product Code: KZD
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility,Company Representative
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 12/16/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/08/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: PIB1000
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/16/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1