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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (BROKEN BOW) BD VACUTAINER® K2 EDTA (K2E) 5.4MG BLOOD COLLECTION TUBES; BLOOD SPECIMEN COLLECTION DEVICE
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BECTON, DICKINSON & CO. (BROKEN BOW) BD VACUTAINER® K2 EDTA (K2E) 5.4MG BLOOD COLLECTION TUBES; BLOOD SPECIMEN COLLECTION DEVICE Back to Search Results
Catalog Number 367835
Device Problem Improper or Incorrect Procedure or Method (2017)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/11/2022
Event Type  malfunction  
Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.Initial reporter state: address information was not able to be obtained, therefore, (b)(6) was used as a place holder.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
 
Event Description
It was reported when using the bd vacutainer® k2 edta (k2e) 5.4mg blood collection tubes, the user identified using the tube after expiration date.The following information was provided by the initial reporter.The customer stated: it was reported that customer ordered vacutainer tubes through mckesson and when they received them they were expired.Customer can not confirm specific date of receipt or event, 3 cases were received.Expired vacutainer tubes were put into use and customer is inquiring what the impact is to the specimen after use.
 
Manufacturer Narrative
H6: investigation summary: bd had not received samples, but one photo was provided for investigation.Based on a review of the device history record for the incident lot, all product specifications and requirements for lot release were met.There were no related quality issues during manufacturing of the product.Bd was unable to duplicate or confirm the customer¿s indicated failure mode because product is expired.Bd can only assure the safety and efficacy of its products across their shelf-life.The products should only be used within their printed labeled expiry dates.
 
Event Description
It was reported when using the bd vacutainer® k2 edta (k2e) 5.4mg blood collection tubes, the user identified using the tube after expiration date.The following information was provided by the initial reporter.The customer stated: it was reported that customer ordered vacutainer tubes through mckesson and when they received them they were expired.Customer can not confirm specific date of receipt or event, 3 cases were received.Expired vacutainer tubes were put into use and customer is inquiring what the impact is to the specimen after use.
 
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Brand Name
BD VACUTAINER® K2 EDTA (K2E) 5.4MG BLOOD COLLECTION TUBES
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 Key13810407
MDR Text Key287586198
Report Number1917413-2022-00146
Device Sequence Number1
Product Code JKA
UDI-Device Identifier00382903678358
UDI-Public00382903678358
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
BK050036
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 04/08/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/18/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Expiration Date06/30/2021
Device Catalogue Number367835
Device Lot Number0044117
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received04/08/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/13/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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