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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (BROKEN BOW) BD VACUTAINER CPT NH: ~130 IU FICOLL: 2.0ML BLOOD SPECIMEN COLLECTION DEVICE

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BECTON, DICKINSON & CO. (BROKEN BOW) BD VACUTAINER CPT NH: ~130 IU FICOLL: 2.0ML BLOOD SPECIMEN COLLECTION DEVICE Back to Search Results
Catalog Number 362780
Device Problem Incorrect, Inadequate or Imprecise Resultor Readings (1535)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 09/01/2020
Event Type  malfunction  
Manufacturer Narrative
Medical device lot #: 0104109 was reported, however, this is not a lot# manufactured for this product line. 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. (b)(4).
 
Event Description
It was reported that after centrifugation with a bd vacutainer® cpt¿ nh: ~130 iu ficoll¿: 2. 0 ml erythrocytes were above the additive. There was no report of patient impact. The following information was provided by the initial reporter, translated from (b)(6) to english: contamination of pbmcs with erythrocytes after centrifugation of bd cpt tubes. Time between blood collection and centrifugation is not clear, centrifugation conditions 1650 rcf for 30 min is acceptable. Erythrocytes above the gel in bd cpt tubes after centrifugation.
 
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Brand NameBD VACUTAINER CPT NH: ~130 IU FICOLL: 2.0ML
Type of DeviceBLOOD 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
brett wilko
9450 south state street
sandy, UT 84070
8015652341
MDR Report Key10580932
MDR Text Key209597045
Report Number1917413-2020-00869
Device Sequence Number1
Product Code JCF
Combination Product (y/n)N
Reporter Country CodeGM
PMA/PMN Number
K891407
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,other,user facility
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 12/16/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/24/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number362780
Device Lot NumberSEE H.10
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/15/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 09/24/2020 Patient Sequence Number: 1
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