Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
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
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

MERIT MEDICAL SYSTEMS, INC. PRESSURE INFUSION BAG; INFUSOR, PRESSURE, FOR I.V. BAGS 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 01/27/2015
Event Type  malfunction  
Event Description
The user reported that the pressure infusion bag would not hold pressure during testing done by the hosp.The device was not used on a patient.
 
Manufacturer Narrative
Device evaluation: one device was returned for evaluation.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 was 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 mfr.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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 pkwy.
south jordan, UT 84095
8012084491
MDR Report Key4548091
MDR Text Key5524541
Report Number1721504-2015-00039
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 Foreign,User Facility,Company Representative
Reporter Occupation Not Applicable
Type of Report Initial
Report Date 01/28/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/19/2015
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 Manufacturer02/13/2015
Is the Reporter a Health Professional? No
Date Manufacturer Received01/28/2015
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
-
-