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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MERIT MEDICAL SYSTEMS, INC. PRESSURE INFUSION BAG; INDFUSOR, PRESSURE, FOR I.V. BAGS
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MERIT MEDICAL SYSTEMS, INC. PRESSURE INFUSION BAG; INDFUSOR, PRESSURE, FOR I.V. BAGS Back to Search Results
Device Problems Air Leak (1008); Loss of or Failure to Bond (1068)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 02/27/2015
Event Type  malfunction  
Event Description
The user reported that the pressure infusion bag is losing pressure during the initial use.The leak was discovered before the procedure began.No harm or injury to the pt was reported.
 
Manufacturer Narrative
Device eval: one used device was returned for eval.The bag was pressure tested and failed the pressure test.The failure was attributed to the bond between the tubing and the bag.The complaint is confirmed.Since the lot number was not provided, the device history record and complaint database could not be reviewed.A supplier corrective action has been requested from the manufacturer.
 
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Brand Name
PRESSURE INFUSION BAG
Type of Device
INDFUSOR, PRESSURE, FOR I.V. BAGS
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 Key4684326
MDR Text Key16180992
Report Number1721504-2015-00076
Device Sequence Number1
Product Code KZD
Combination Product (y/n)N
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,User Facility,Company Representative
Reporter Occupation Not Applicable
Type of Report Initial
Report Date 03/16/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/09/2015
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Was Device Available for Evaluation? Yes
Date Returned to Manufacturer03/16/2015
Is the Reporter a Health Professional? No
Date Manufacturer Received03/16/2015
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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