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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 Result or Readings (1535)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 03/15/2019
Event Type  malfunction  
Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.Initial reporter phone# (b)(6).Initial reporter e-mail: (b)(6).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 that the bd vacutainer® cpt¿ nh: ~130 iu ficoll¿: 2.0ml experienced clotting.The following information was provided by the customer: i used the tubes that you sent me for experiments before christmas, and for experiments just two weeks ago, but today, i have had the same issue as with the previous lot of tubes, where the red blood cells won't go through the filter.This is extremely frustrating as the blood is very valuable.The tubes are due to expire on the 31st of this month, and have been kept at room temperature as required, and worked just two weeks ago.
 
Manufacturer Narrative
Investigation: investigation summary: bd had not received samples or photos from the customer facility for evaluation; therefore, the investigation was limited.A review of the device history record was completed for the incident lot and, based on this review, all product specifications and requirements for lot release were met; there were no related quality non-conformances during manufacturing of the product.Bd has initiated further investigation relating to this issue through capa#373360.The investigation is still on-going and improvements will be made as the potential causes of this issue are identified.Investigation conclusion: as no samples or photos were received for evaluation, the customer's indicated failure mode was not observed by bd.However, further investigation has been initiated through capa#373360.The investigation is still on-going and improvements will be made as the potential causes are identified.Root cause description: although no samples or photos were available for evaluation, bd has initiated further investigation through capa#373360 to identify the potential root cause(s).Rationale: based on an assessment of severity and frequency, it was determined that a capa is required at this time in order to determine the root cause associated with this issue and implement corrective actions.The investigation is currently on-going and further improvements will be made as the potential root cause(s) are identified.
 
Event Description
It was reported that the bd vacutainer® cpt¿ nh: ~130 iu ficoll¿: 2.0ml experienced clotting.The following information was provided by the customer: i used the tubes that you sent me for experiments before christmas, and for experiments just two weeks ago, but today, i have had the same issue as with the previous lot of tubes, where the red blood cells won't go through the filter.This is extremely frustrating as the blood is very valuable.The tubes are due to expire on the 31st of this month, and have been kept at room temperature as required, and worked just two weeks ago.
 
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Brand Name
BD VACUTAINER® CPT¿ NH: ~130 IU FICOLL¿: 2.0ML
Type of Device
BLOOD SPECIMEN COLLECTION DEVICE
Manufacturer (Section D)
BECTON, DICKINSON & CO. (BROKEN BOW)
150 south 1st avenue
broken bow NE 68822
MDR Report Key8470383
MDR Text Key140924709
Report Number1917413-2019-01083
Device Sequence Number1
Product Code JCF
Combination Product (y/n)N
PMA/PMN Number
K891407
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,other,user facility
Type of Report Initial,Followup
Report Date 05/28/2019
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
Device Operator Other
Device Expiration Date03/31/2019
Device Catalogue Number362780
Device Lot Number8059582
Initial Date Manufacturer Received 03/15/2019
Initial Date FDA Received04/01/2019
Supplement Dates Manufacturer Received03/15/2019
Supplement Dates FDA Received05/28/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
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