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

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 10/11/2019

Event Type  malfunction  

Manufacturer Narrative

(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 30 bd vacutainer® cpt¿ nh: ~130 iu ficoll¿: 2.0ml experienced hemolysis during use.The following information was provided by the initial reporter: cpt, isolated cells contaminated with erythrocytes and low vitality laboratory receives centrifuged cpt from participants of a clinical study; the cells collected above the gel are contaminated with erythrocytes, often the sample looks hemolytic before further processing; total number of cells is high, 20-30 million cells, but a large proportion of them are probably erythrocytes.The vitality of the cells is below 87% (study sponsor gives 90% as a minimum requirement).After freezing (with dmso, protocol dictated by study sponsor), the vitality is> 90% and the cell count is 7-8 million.Study sites centrifuge 17 min between 1650 rcf and 1800 rcf.

Event Description

It was reported that 30 bd vacutainer® cpt¿ nh: ~130 iu ficoll¿: 2.0ml experienced hemolysis during use.The following information was provided by the initial reporter: cpt, isolated cells contaminated with erythrocytes and low vitality laboratory receives centrifuged cpt from participants of a clinical study; the cells collected above the gel are contaminated with erythrocytes, often the sample looks hemolytic before further processing; total number of cells is high, 20-30 million cells, but a large proportion of them are probably erythrocytes.The vitality of the cells is below 87% (study sponsor gives 90% as a minimum requirement).After freezing (with dmso, protocol dictated by study sponsor), the vitality is> 90% and the cell count is 7-8 million.Study sites centrifuge 17 min between 1650 rcf and 1800 rcf.

Manufacturer Narrative

H.6.Investigation: 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 hemolysis 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.Hemolysis can be caused by many sources, including certain patient pathological conditions, improper specimen collection, specimen processing, and specimen transport.Specimen collection factors that can contribute to hemolysis range from prolonged tourniquet time and improper venipuncture technique to transferring a sample from a syringe draw or iv catheter.Specimen processing factors include vigorous mixing or shaking of the specimen, not allowing the specimen to clot for the recommended amount of time, prolonged contact of serum or plasma with cells, and exposure to excessive heat or cold.Finally, mechanical trauma and other adverse conditions during transport of tubes can result in hemolysis.H3 other text : see h.10.

• 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 Key: 9273518
• MDR Text Key: 191174352
• Report Number: 1917413-2019-02304
• Device Sequence Number: 1
• Product Code: JCF
• Combination Product (y/n): N
• PMA/PMN Number: K891407
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Type of Report: Initial,Followup
• Report Date: 02/10/2020

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 Date: 03/31/2019
• Device Catalogue Number: 362780
• Device Lot Number: 8059582
• Initial Date Manufacturer Received: 10/18/2019
• Initial Date FDA Received: 11/04/2019
• Supplement Dates Manufacturer Received: 10/18/2019
• Supplement Dates FDA Received: 02/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other