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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MERIT MEDICAL SYSTEMS, INC. PRESSURE INFUSION BAG; INFUSOR, PRESSURE, FOR I.V. BAGS
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MERIT MEDICAL SYSTEMS, INC. PRESSURE INFUSION BAG; INFUSOR, PRESSURE, FOR I.V. BAGS Back to Search Results
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
No device is expected to be returned for evaluation.Since the lot number was not provided, the device history record and complaint database could not be reviewed.Because the unit was not returned, the root cause could not be determined.If the device is returned in the future this investigation will be reopened and a follow up submitted.
 
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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 Key4412642
MDR Text Key5275256
Report Number1721504-2015-00005
Device Sequence Number1
Product Code KZD
Combination Product (y/n)N
Reporter Country CodeAS
PMA/PMN Number
EXEMPT
Number of Events Reported1
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 Received01/08/2015
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberPIB1000
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received12/16/2014
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 Number1
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