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 Consequences Or Impact To Patient (2199)

Event Date 07/13/2020

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.(b)(4).

Event Description

It was reported after use the bd vacutainer® cpt¿ nh: ~130 iu ficoll¿: 2.0ml had poor barrier separation of the sample.This event occurred 2 times.The following information was provided by the initial reporter: the customer stated "centrifugation did not succeed, even after 2 different tries with 2 different setups." new additional information: "customer emailed, she claims that she discovered the mistake they made, they were confused between rpm and g force during centrifugation.Follow up information: customer states device is working fine and pbmc's amount is very sufficient.

Manufacturer Narrative

H.6.Investigation: bd had not received samples, but 3 photos were provided by the customer for investigation.The photos were reviewed and the indicated failure mode for poor barrier separation with the incident lot was observed.Based on a review of the device history record for the incident lot, all product specifications and requirements for lot release were met.There were no related quality non-conformances during manufacturing of the product.The customer informed bd that during centrifugation there was a confusion between rpm and g force.The necessary adjustments were made and reported that the separation worked fine and also pbmc's amount was sufficient.

Event Description

It was reported after use the bd vacutainer® cpt¿ nh: ~130 iu ficoll¿: 2.0ml had poor barrier separation of the sample.This event occurred 2 times.The following information was provided by the initial reporter: the customer stated "centrifugation did not succeed, even after 2 different tries with 2 different setups." new additional information: "customer emailed, she claims that she discovered the mistake they made, they were confused between rpm and g force during centrifugation.Follow up information: customer states device is working fine and pbmc's amount is very sufficient.

• 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: 10356657
• MDR Text Key: 202750375
• Report Number: 1917413-2020-00643
• 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: 08/31/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/03/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 09/30/2020
• Device Catalogue Number: 362780
• Device Lot Number: 9256425
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/13/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other