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 01/20/2020

Event Type  malfunction  

Manufacturer Narrative

Additional lot number: 9256425; additional expiration date: 2019-09-13.A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.Additional manufacture date: 2020-09-30.

Event Description

It was reported that a bd vacutainer® cpt¿ nh: ~130 iu ficoll¿: 2.0ml had poor barrier separation after centrifugation.The following information was provided by the initial reporter: "the costumer complained that sometimes after centrifugation , separation doesn¿t occur at all and the gel just come down only after second centrifugation the separation occurred and even then not always they get concentrated mononuclear cells layer but dispersed layer.In other cases after one centrifugation the mononuclear cells layer comes out dispersed".

Manufacturer Narrative

H.6.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 low yield 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 capa.1092363 the investigation is still on-going and improvements will be made as the potential causes of this issue are identified.

Event Description

It was reported that a bd vacutainer® cpt¿ nh: ~130 iu ficoll¿: 2.0ml had poor barrier separation after centrifugation.The following information was provided by the initial reporter: "the costumer complained that sometimes after centrifugation , separation doesn¿t occur at all and the gel just come down only after second centrifugation the separation occurred and even then not always they get concentrated mononuclear cells layer but dispersed layer.In other cases after one centrifugation the mononuclear cells layer comes out dispersed.".

• 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: 9683347
• MDR Text Key: 189176093
• Report Number: 1917413-2020-00086
• 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: 02/26/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/07/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 04/30/2020
• Device Catalogue Number: 362780
• Device Lot Number: 9087924
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other