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 09/01/2020

Event Type  malfunction  

Manufacturer Narrative

Medical device lot #: 0104109 was reported, however, this is not a lot# manufactured for this product line.Medical device expiration date: unknown.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.(b)(4).

Event Description

It was reported that after centrifugation with a bd vacutainer® cpt¿ nh: ~130 iu ficoll¿: 2.0 ml erythrocytes were above the additive.There was no report of patient impact.The following information was provided by the initial reporter, translated from (b)(6) to english: contamination of pbmcs with erythrocytes after centrifugation of bd cpt tubes.Time between blood collection and centrifugation is not clear, centrifugation conditions 1650 rcf for 30 min is acceptable.Erythrocytes above the gel in bd cpt tubes after centrifugation.

Manufacturer Narrative

H6: investigation summary: bd had not received samples, but 2 photos were provided for investigation.The photos were reviewed and the indicated failure mode for poor barrier formation was observed.Additionally, retention samples of the incident lot were selected from bd inventory for evaluation and upon completion, no issues relating to poor barrier formation were observed.No difficulties were encountered during blood collection and all tubes appeared to exhibit proper fill.Bd was unable to duplicate or confirm the customer¿s indicated failure (poor barrier) because the defect was not evident in the testing of the retention lot samples.Evaluation of both retain and control samples tested were acceptable 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 issues during manufacturing of the product.This complaint has been confirmed based on the photos provided.H3 other text : see h.10.

Event Description

It was reported that after centrifugation with a bd vacutainer® cpt¿ nh: 130 iu ficoll¿: 2.0ml erythrocytes were above the additive.There was no report of patient impact.The following information was provided by the initial reporter, translated from german to english: contamination of pbmcs with erythrocytes after centrifugation of bd cpt tubes.Time between blood collection and centrifugation is not clear, centrifugation conditions 1650 rcf for 30 min is acceptable.Erythrocytes above the gel in bd cpt tubes after centrifugation.

• 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: 10580932
• MDR Text Key: 209597045
• Report Number: 1917413-2020-00869
• 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: 12/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/24/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 362780
• Device Lot Number: SEE H.10
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/15/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other