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: BD CARIBE LTD. BD MICROTAINER® TUBES WITH LH (LITHIUM HEPARIN); 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
 

BD CARIBE LTD. BD MICROTAINER® TUBES WITH LH (LITHIUM HEPARIN); BLOOD SPECIMEN COLLECTION DEVICE Back to Search Results
Catalog Number 365965
Medical Device Problem Code Short Fill (1575)
Health Effect - Clinical Code No Information (3190)
Date of Event 12/27/2016
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
The date received by manufacturer has been used for this field.Bd had not received samples or photos from the customer facility for evaluation; therefore, the investigation was limited.Additionally, bd was unable to determine the specific lot number associated with this complaint.Therefore, a review of the device history record could not be conducted.
 
Event or Problem Description
It was reported that bd microtainer® tubes with lh (lithium heparin) were under filling.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
BD MICROTAINER® TUBES WITH LH (LITHIUM HEPARIN)
Common Device Name
BLOOD SPECIMEN COLLECTION DEVICE
Manufacturer (Section D)
BD CARIBE LTD.
road 31
k.m. 24.3
juncos
MDR Report Key7475850
Report Number2618282-2018-00363
Device Sequence Number19073173
Product Code JKA
UDI-Device Identifier50382903659659
UDI-Public50382903659659
Combination Product (Y/N)N
Initial Reporter StateCA
Initial Reporter CountryUS
PMA/510(K) Number
K991702
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative,other
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 04/30/2018
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 Catalogue Number365965
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 12/27/2016
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;
-
-