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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. BAG
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MERIT MEDICAL SYSTEMS, INC. PRESSURE INFUSION BAG; INFUSOR, PRESSURE, FOR I.V. BAG Back to Search Results
Catalog Number PIB500
Device Problems Air Leak (1008); Loss of or Failure to Bond (1068)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 05/15/2014
Event Type  malfunction  
Event Description
It was reported that the pressure infusion bag slowly deflated.The bag was exchanged for a new device when this was discovered.No clinical information was provided by the customer.Multiple attempts were made to gain this information without success.No harm or injury to the patient was reported.
 
Manufacturer Narrative
The user reported a second lot number (i677857) with a manufacturing date of 04/18/2014 and an expiration date of 03/31/2014.Device evaluation: the suspect device has not been returned for evaluation.A follow up report will be submitted when the evaluation has been completed.
 
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Brand Name
PRESSURE INFUSION BAG
Type of Device
INFUSOR, PRESSURE, FOR I.V. BAG
Manufacturer (Section D)
MERIT MEDICAL SYSTEMS, INC.
south jordan UT
Manufacturer Contact
jerry mcphie
1600 west merit pkwy.
south jordan, UT 84095
8012084491
MDR Report Key3966419
MDR Text Key21735361
Report Number1721504-2014-00120
Device Sequence Number1
Product Code KZD
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type User Facility,Company Representative
Reporter Occupation Not Applicable
Type of Report Initial
Report Date 05/27/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/25/2014
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date03/31/2017
Device Catalogue NumberPIB500
Device Lot NumberI668545
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Date Manufacturer Received05/27/2014
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/01/2013
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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