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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CARDINAL HEALTH 200, INC. PATIENT IDENTIFICATION BAND; INFANT/PARENT ID BAND
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CARDINAL HEALTH 200, INC. PATIENT IDENTIFICATION BAND; INFANT/PARENT ID BAND Back to Search Results
Device Problem Manufacturing, Packaging or Shipping Problem (2975)
Patient Problem No Information (3190)
Event Date 01/27/2014
Event Type  malfunction  
Event Description
Our l&d nurses have noticed that the infant/parent id bands in some of the delivery packs are slightly different.The different band is slick all the way across the band.The old band has a dull finish in the area where you write the patient name.The slick version doesn't hold ink well and the nurses are observing the names blurring and coming off.The manufacture of our delivery packs is aware and has requested samples.Precision dynamics, the manufacture of the armband is aware and coordinating with cardinal to review the sample bands.
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manufacturer response for infant/parent id band inside cardinal/sri hybrid pack, cardinal pack/ precision dynamics armband (per site reporter).
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cardinal requested that we return samples of the bands.We plan to ship them out on (b)(4) 2014.
 
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Brand Name
PATIENT IDENTIFICATION BAND
Type of Device
INFANT/PARENT ID BAND
Manufacturer (Section D)
CARDINAL HEALTH 200, INC.
1500 waukegan road
mcgaw park CA 60085
MDR Report Key3672445
MDR Text Key4341439
Report Number3672445
Device Sequence Number2
Product Code KNA
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Type of Report Initial
Report Date 01/31/2014
2 Devices were Involved in the Event: 1   2  
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Invalid Data
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA01/31/2014
Event Location Hospital
Date Report to Manufacturer03/11/2014
Initial Date Manufacturer Received Not provided
Initial Date FDA Received01/31/2014
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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