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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ANHUI KANGDA TCBINF022AE IV ADMINISTRATION SET

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ANHUI KANGDA TCBINF022AE IV ADMINISTRATION SET Back to Search Results
Catalog Number TCBINF022ZE
Device Problem Appropriate Term/Code Not Available (3191)
Patient Problem No Patient Involvement (2645)
Event Type  malfunction  
Event Description
A strand of hair was found inside a sealed package of tcbinf022ae. Please note this was not inside the fluid pathway, it was completely outside of the tubing but contained within the packaging. We became aware of this issue on 5/9/2016.
 
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Brand NameTCBINF022AE
Type of DeviceIV ADMINISTRATION SET
Manufacturer (Section D)
ANHUI KANGDA
no. 188 tiankang road
,yangcun town
tianchang city, anhui 23904
CH 23904
MDR Report Key5745536
MDR Text Key48053130
Report Number3008782867-2016-00001
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 Distributor
Reporter Occupation Pharmacist
Type of Report Initial
Report Date 06/08/2016,05/09/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/23/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Pharmacist
Device Expiration Date02/18/2018
Device Catalogue NumberTCBINF022ZE
Device Lot Number2015032366
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA06/08/2016
Distributor Facility Aware Date05/09/2016
Device Age1 YR
Event Location Other
Date Report to Manufacturer06/08/2016
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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