MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (BROKEN BOW) BD VACUTAINER® CPT¿ NH FICOLL¿; 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 11/11/2019

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 the bd vacutainer® cpt¿ nh ficoll¿ did not separate the cells properly during use after centrifugation.This occurred on 85 separate occasions, but the dates and/or patient information are unknown.The following information was provided by the initial reporter, translated from (b)(6) to english: "customer informs us that after centrifugation, the separation is not done correctly.This happens in 14% of the tubes we send (600)".

Event Description

It was reported that the bd vacutainer® cpt¿ nh ficoll¿ did not separate the cells properly during use after centrifugation.This occurred on 85 separate occasions, but the dates and/or patient information are unknown.The following information was provided by the initial reporter, translated from spanish to english: "customer informs us that after centrifugation, the separation is not done correctly.This happens in 14% of the tubes we send (600).".

Manufacturer Narrative

H.6.Investigation summary bd received samples and photos from 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.Additionally, evaluation/testing of the customer samples was performed and no issues were identified.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 and potential causes have been identified.As a result, corrective actions have been established and are in the process of being implemented.

• Brand Name: BD VACUTAINER® CPT¿ NH FICOLL¿
• 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: 9396504
• MDR Text Key: 188202829
• Report Number: 1917413-2019-02450
• 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: 01/14/2020

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: 06/30/2020
• Device Catalogue Number: 362780
• Device Lot Number: 9155900
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/26/2019
• Initial Date Manufacturer Received: 11/11/2019
• Initial Date FDA Received: 12/02/2019
• Supplement Dates Manufacturer Received: 11/11/2019
• Supplement Dates FDA Received: 01/14/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other