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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: HOSPIRA, INC. ADD-VANTAGE ADDAPTOR; SET, I.V. FLUID TRANSFER
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HOSPIRA, INC. ADD-VANTAGE ADDAPTOR; SET, I.V. FLUID TRANSFER Back to Search Results
Catalog Number 11410-01
Device Problems Manufacturing, Packaging or Shipping Problem (2975); Protective Measures Problem (3015)
Patient Problem No Patient Involvement (2645)
Event Type  malfunction  
Event Description
A potential safety hazard was identified while preparing for the 1st phase of implementation of the iso (international organization of standardization) enteral feeding connector standards.The international color for enteral feedings is "purple".We currently use an add-vantage adaptor for mixing of ivpb's (intravenous piggyback).The cap on this product is purple.This has potential impact of patient safety.This is not an actual incident - no patient event.It is a concern from a healthcare provider perspective in regards to iso guidelines.Manufacturer response for ivpb mixing adapter, add-vantage adaptor (per site reporter): a pharmacist did submit a concern with this product to hospira but has not received any feedback at this time.
 
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Brand Name
ADD-VANTAGE ADDAPTOR
Type of Device
SET, I.V. FLUID TRANSFER
Manufacturer (Section D)
HOSPIRA, INC.
275 n. field dr., bldg. h2
lake forest IL 60045
MDR Report Key5055911
MDR Text Key24992847
Report Number5055911
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Other
Report Date 08/13/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/04/2015
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator No Information
Device Catalogue Number11410-01
Device Lot Number524636
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA08/13/2015
Date Report to Manufacturer08/13/2015
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
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