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 UNSPECIFIED BD VACUTAINER® BLOOD COLLECTION TUBE; 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 UNSPECIFIED BD VACUTAINER® BLOOD COLLECTION TUBE; BLOOD SPECIMEN COLLECTION DEVICE Back to Search Results
Catalog Number UNKNOWN
Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)
Patient Problem Test Result (2695)
Event Date 05/07/2020
Event Type  Injury  
Manufacturer Narrative
Unknown manufacturer: there are multiple bd locations where this unspecified bd device may have been manufactured.A catalog and lot number could not be confirmed for this incident and without this information we are unable to determine where the device was manufactured.Therefore, bd corporate headquarters in (b)(4) has been listed and the (b)(4) fda registration number has been used for the manufacture report number.Date of event: unknown.The date received by manufacturer has been used for this field.Medical device expiration date: unknown.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.
 
Event Description
It was reported that a patient's blood test came out "critically high" during use after having it drawn into the unspecified bd vacutainer® blood collection tube.The patient returned to the emergency room, where a new blood test was done with the same type of tube that came out "normal".This complaint was created to capture the 1st of 2 related incidents.The following information was provided by the initial reporter: "three years ago a pt blood test came up critically high via green sodium/lithium tube.Pt returned to er; subsequent test with same type tube was normal.Site worked with bd and cause remains unknown." "pt returned to er; subsequent test with same type tube was normal.".
 
Event Description
It was reported that a patient's blood test came out "critically high" during use after having it drawn into the unspecified bd vacutainer® blood collection tube.The patient returned to the emergency room, where a new blood test was done with the same type of tube that came out "normal".This complaint was created to capture the 1st of 2 related incidents.The following information was provided by the initial reporter: "three years ago a pt blood test came up critically high via green sodium/lithium tube.Pt returned to er; subsequent test with same type tube was normal.Site worked with bd and cause remains unknown." "pt returned to er; subsequent test with same type tube was normal.".
 
Manufacturer Narrative
H.6.Investigation: bd had not received samples or photos from the customer facility for evaluation.Additionally, bd was unable to determine the specific material or lot number associated with this complaint.Therefore, a review of the device history record could not be conducted.Bd had made multiple attempts to reach the customer in order to gather more information on the catalog and lot number; however, bd had not received a response from the customer.This complaint will be closed without further investigation at this time.If additional information is made available, this complaint will be reopened to assess the level of investigation needed.H3 other text : see h.10.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
UNSPECIFIED BD VACUTAINER® BLOOD COLLECTION TUBE
Type of Device
BLOOD SPECIMEN COLLECTION DEVICE
Manufacturer (Section D)
BECTON DICKINSON
1 becton drive
franklin lakes NJ 07417
MDR Report Key10097379
MDR Text Key195366435
Report Number2243072-2020-00824
Device Sequence Number1
Product Code JKA
Combination Product (y/n)N
PMA/PMN Number
UNKNOWN
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,other,use
Type of Report Initial,Followup
Report Date 06/02/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/28/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue NumberUNKNOWN
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Date Manufacturer Received05/07/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
-
-