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: HOSPIRA, LTD NDHP 0.2 MICRN HP CL; 80FPA
  • 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
 

HOSPIRA, LTD NDHP 0.2 MICRN HP CL; 80FPA Back to Search Results
Catalog Number 20668
Device Problem Particulates (1451)
Patient Problem No Patient Involvement (2645)
Event Date 03/01/2014
Event Type  malfunction  
Manufacturer Narrative
The device was received on 3/31/2014.Investigation is not complete.This report represents all the information known by the reporter upon query by hospira personnel.Upon fda request, this report is being submitted to report the correct mfr number.
 
Event Description
The customer contact reported particulate.The customer contact reported that after the tubing set was removed from the packaging, particulate was noted in the tubing near the clave y-site or the option-lok male adapter.The customer contact reported the white particulate looked like either scratch marks or particulate within the wall of the tubing.The tubing set was replaced and the therapy was initiated.No additional information was provided.
 
Manufacturer Narrative
Subsequent to the submission of initial medwatch mfr report #9615050-2014-02892 it was noted the manufacturer report # for (b)(4) was inadvertently selected instead of the intended (b)(4) manufacturer#.
 
Event Description
The customer contact reported particulate.The customer contact reported that after the tubing set was removed from the packaging, particulate was noted in the tubing near the clave y-site or the option-lok male adapter.The customer contact reported the white particulate looked like either scratch marks or particulate within the wall of the tubing.The tubing set was replaced and the therapy was initiated.No additional information was provided.
 
Manufacturer Narrative
One opened device was received and evaluated.The device passed testing.No particulate was noted in the tubing set; however, a white spot on the female adapter was noted which is the injection point during manufacturing for the female adapter.Upon fda request, this report is being submitted to report the correct mfr number.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
NDHP 0.2 MICRN HP CL
Type of Device
80FPA
Manufacturer (Section D)
HOSPIRA, LTD
9613251
carretera sanchez km. 18 1/2
haina sancristobal
DR 
MDR Report Key5209497
MDR Text Key193711977
Report Number9613251-2015-00065
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
PMA/PMN Number
K113683
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,other
Type of Report Initial,Followup,Followup
Report Date 03/24/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number20668
Device Lot Number341234W
Was Device Available for Evaluation? Yes
Initial Date Manufacturer Received 03/24/2014
Initial Date FDA Received11/07/2015
Supplement Dates Manufacturer Received04/23/2014
04/23/2014
Supplement Dates FDA Received06/03/2020
11/07/2015
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
-
-