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 03/17/2020

Event Type  malfunction  

Manufacturer Narrative

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 180 bd vacutainers® cpt¿ nh: ~130 iu ficoll¿: 2.0ml experienced poor separator movement which was noted after use.The following information was provided by the initial reporter: during a new study, the bd cpt tubes did not work as expected.Out of 30 tubes there was no gel movement at 30%, the whole blood was still above the gel after centrifugation.The yield was also lower than expected, 2-5 million leukocytes per tube.Centrifugation conditions were okay, 25min at 1800 rcf and 22°c (temperature controlled centrifuge).In the tubes where no separation had occurred, the supernatant was re-suspended and transferred to a second bd cpt tube.After renewed centrifugation, the separation of the pbmcs had also worked for these samples.The customer is an experienced user, in previous studies she may have had one or two tubes with this phenomenon, but never 30%.

Event Description

It was reported that 180 bd vacutainers® cpt¿ nh: ~130 iu ficoll¿: 2.0ml experienced poor separator movement which was noted after use.The following information was provided by the initial reporter: during a new study, the bd cpt tubes did not work as expected.Out of 30 tubes there was no gel movement at 30%, the whole blood was still above the gel after centrifugation.The yield was also lower than expected, 2-5 million leukocytes per tube.Centrifugation conditions were okay, 25min at 1800 rcf and 22°c (temperature controlled centrifuge).In the tubes where no separation had occurred, the supernatant was re-suspended and transferred to a second bd cpt tube.After renewed centrifugation, the separation of the pbmcs had also worked for these samples.The customer is an experienced user, in previous studies she may have had one or two tubes with this phenomenon, but never 30%.

Manufacturer Narrative

H.6.Investigation summary: bd had not received samples or photos from the customer facility for evaluation.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.

• 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: 9933694
• MDR Text Key: 187761258
• Report Number: 1917413-2020-00368
• 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: distributor,foreign,other
• Type of Report: Initial,Followup
• Report Date: 05/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/07/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 11/30/2020
• Device Catalogue Number: 362780
• Device Lot Number: 9315088
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/18/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other