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 & CO. (BROKEN BOW) BD TUBE K2EDTA PLH 13X75 2.0 SLBL LAV JLP; 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 & CO. (BROKEN BOW) BD TUBE K2EDTA PLH 13X75 2.0 SLBL LAV JLP; BLOOD SPECIMEN COLLECTION DEVICE Back to Search Results
Catalog Number 367846
Device Problem Inaccurate Information (4051)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/29/2022
Event Type  malfunction  
Event Description
It was reported when using the bd tube k2edta plh 13x75 2.0 slbl lav jlp there was incorrect label information.This event occurred 2 times.The following information was provided by the initial reporter.The customer stated: "the line drawn on the wall of the tube was partially missing.".
 
Manufacturer Narrative
A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
 
Manufacturer Narrative
H.6 investigation summary bd received 3 samples and 3 photos from the customer in support of this complaint.The samples and photos show that there is a gap in the circumference of the fill line and missing print.The device history records were reviewed, a quality notification was generated for partial missing banding.Impacted product was dispositioned per procedure.All process and final inspections comply with specification requirements.Bd was able to confirm the customer¿s indicated failure mode with the samples and photos provided.The exact cause for the customer¿s failure mode could not be determined.H3 other text : see h.10.
 
Event Description
It was reported when using the bd tube k2edta plh 13x75 2.0 slbl lav jlp there was incorrect label information.This event occurred 2 times.The following information was provided by the initial reporter.The customer stated: "the line drawn on the wall of the tube was partially missing.".
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
BD TUBE K2EDTA PLH 13X75 2.0 SLBL LAV JLP
Type of Device
BLOOD SPECIMEN COLLECTION DEVICE
Manufacturer (Section D)
BECTON, DICKINSON & CO. (BROKEN BOW)
150 south 1st avenue
broken bow NE 68822
Manufacturer (Section G)
BECTON, DICKINSON & CO. (BROKEN BOW)
150 south 1st avenue
broken bow NE 68822
Manufacturer Contact
phillip emmert
9450 south state street
sandy, UT 84070
8015296192
MDR Report Key15135551
MDR Text Key304425477
Report Number1917413-2022-00437
Device Sequence Number1
Product Code JKA
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
NA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 08/08/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/29/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Expiration Date01/31/2023
Device Catalogue Number367846
Device Lot Number1288688
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/13/2022
Is the Reporter a Health Professional? Yes
Date Manufacturer Received08/08/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/15/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
-
-