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: BECTON, DICKINSON AND COMPANY (BD) BD VACUTAINER® BARRICOR¿ LITHIUM HEPARIN PLASMAN BLOOD COLLECTION TUBES; BLOOD SPECIMEN COLLECTION DEVICE
  • 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
 

BECTON, DICKINSON AND COMPANY (BD) BD VACUTAINER® BARRICOR¿ LITHIUM HEPARIN PLASMAN BLOOD COLLECTION TUBES; BLOOD SPECIMEN COLLECTION DEVICE Back to Search Results
Catalog Number 365047
Medical Device Problem Code Incorrect Or Inadequate Test Results (2456)
Health Effect - Clinical Code No Known Impact Or Consequence To Patient (2692)
Date of Event 07/05/2017
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.Bd had not received samples, but photos were provided by the customer facility for investigation.The photos 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® barricor¿ lithium heparin plasman blood collection tubes had "separator position".
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
BD VACUTAINER® BARRICOR¿ LITHIUM HEPARIN PLASMAN BLOOD COLLECTION TUBES
Common Device Name
BLOOD SPECIMEN COLLECTION DEVICE
Manufacturer (Section D)
BECTON, DICKINSON AND COMPANY (BD)
belliver way
belliver industrial estate
plymouth
MDR Report Key7475734
Report Number9617032-2018-00947
Device Sequence Number1339698
Product Code JKA
UDI-Device Identifier50382903650472
UDI-Public50382903650472
Combination Product (Y/N)N
Initial Reporter StateTN
Initial Reporter CountryUS
PMA/510(K) Number
K160657
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 Date05/31/2018
Device Catalogue Number365047
Device Lot Number6333935
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 07/05/2017
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;
-
-