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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 Known Impact Or Consequence To Patient (2692)
Event Date 07/24/2019
Event Type  malfunction  
Manufacturer Narrative
Investigation summary: bd had not received samples, but photos were provided by the customer facility for investigation. The photos were evaluated and the customer's indicated failure mode for poor barrier separation with the incident lot was observed. 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 a capa. The investigation is still on-going and improvements will be made as the potential causes of this issue are identified. Investigation conclusion: based on evaluation of the customer photos, the customer¿s indicated failure mode for poor barrier separation with the incident lot was observed. Further investigation has been initiated through a capa. The investigation is still on-going and improvements will be made as the potential causes are identified. Root cause description: a capa has been initiated to document further investigation and root cause analysis relating to this issue. The investigation is currently on-going and will be updated as the potential root cause(s) are identified. 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 has been reported that the bd vacutainer® cpt¿ nh: 130 iu ficoll¿: 2. 0ml has been found experiencing five occurrences of poor gel separation during use. The following has been provided by the initial reporter: customer called to complain about insufficient separation of pbmcs and contamination with red blood cells in 5 out of 11 cpt tubes after centrifugation. After speaking to the customer it became clear that this is not a product related issue but rather a protocol mistake. It was recommended to increase centrifugation force and duration. Main problem is that the samples sit up to 17 hours before being centrifuged. This is far from bd protocol recommendations so we cannot guarantee perfect results after such an extended centrifugation delay.
 
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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 Key8875029
MDR Text Key154151761
Report Number1917413-2019-01885
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
Report Date 07/31/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/08/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Expiration Date11/30/2019
Device Catalogue Number362780
Device Lot Number8302637
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 Received07/24/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/29/2018
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: 08/08/2019 Patient Sequence Number: 1
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