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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET; BLOOD SPECIMEN COLLECTION DEVICE
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BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET; BLOOD SPECIMEN COLLECTION DEVICE Back to Search Results
Catalog Number 367323
Medical Device Problem Code Device Markings/Labelling Problem (2911)
Health Effect - Clinical Code No Known Impact Or Consequence To Patient (2692)
Date of Event 01/16/2017
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.Multiple devices; medical device type: fpa.Common device name: intravascular administration set.Bd received samples from the customer facility for investigation.The samples were evaluated and the customer's indicated failure mode for (b)(6) with the incident lot was not observed.
 
Event or Problem Description
It was reported that bd vacutainer® push button blood collection set had an "incorrect label".
 
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Brand Name
BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET
Common Device Name
BLOOD SPECIMEN COLLECTION DEVICE
Manufacturer (Section D)
BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
9450 south state street
sandy UT 84070
MDR Report Key7475685
Report Number1710034-2018-00516
Device Sequence Number238981
Product Code JKA
UDI-Device Identifier50382903673235
UDI-Public50382903673235
Combination Product (Y/N)N
Initial Reporter StateWI
Initial Reporter CountryUS
PMA/510(K) Number
K030573
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source consumer,other,user facility
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 04/24/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Operator of Device Other
Device Expiration Date10/31/2018
Device Catalogue Number367323
Device Lot Number6285788
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/26/2017
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 01/16/2017
Initial Report FDA Received Date05/01/2018
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Outcome Attributed to Adverse Event Other;
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