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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. GAGS
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MERIT MEDICAL SYSTEMS, INC. PRESSURE INFUSION BAG; INFUSOR, PRESSURE, FOR I.V. GAGS 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 09/08/2014
Event Type  malfunction  
Event Description
The user reported that the pressure infusiuon bag is losing pressure after being inflated.No harm or injury to the patient was reported.
 
Manufacturer Narrative
One used device was returned for evaluation.Since the lot number was not provided, the device history record and complaint database could not be reviewed.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.A supplier corrective action has been requested from the manufacturer.
 
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Brand Name
PRESSURE INFUSION BAG
Type of Device
INFUSOR, PRESSURE, FOR I.V. GAGS
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 Key4138709
MDR Text Key4917486
Report Number1721504-2014-00240
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 Health Professional,User Facility,Company Representative
Reporter Occupation Not Applicable
Type of Report Initial
Report Date 09/08/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/01/2014
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberPIB500
Was Device Available for Evaluation? Yes
Date Returned to Manufacturer09/15/2014
Is the Reporter a Health Professional? No
Date Manufacturer Received09/08/2014
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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