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 Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/15/2023

Event Type  malfunction  

Manufacturer Narrative

There were multiple lot numbers reported to be involved.The information for each additional lot number is as follows: d4.Medical device lot #: 2341889; d4.Medical device expiration date: 2023-12-31; h4.Device manufacture date: 2022-12-07.D4.Medical device lot #: 3024227; d4.Medical device expiration date: 2024-01-31; h4.Device manufacture date: 2023-01-24.D4.Medical device lot #: 3046964; d4.Medical device expiration date: 2024-02-29; h4.Device manufacture date: 2023-02-15.D4.Medical device lot #: 3046965; d4.Medical device expiration date: 2024-02-29; h4.Device manufacture date: 2023-02-15.D4.Medical device lot #: 3142380; d4.Medical device expiration date: 2024-05-31; h4.Device manufacture date: 2023-05-22.H.3.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 while using bd vacutainer® cpt¿ nh: ~130 iu ficoll¿: 2.0ml that there was poor barrier separation of sample/ insufficient additive quantity.The following information was provided by the initial reporter: medpace is collecting blood samples from patients and controls.In europe they encounter issues with red blood cell contamination and slanted gel barriers.This is not related to a specific patient group as it can be seen in healthy controls as well.

Manufacturer Narrative

Material #: 362780.Lot/batch #: 2341889, 3142380, 3024227, 3046964, 3046965, and 3142380.Bd had not received samples or photos for evaluation.Therefore, 59 retention samples of the incident lots were selected from bd inventory for evaluation and upon completion, no issues relating to poor barrier separation or poor plasma were observed.Complaints for sample quality were not under statistical control for the month of august 2023, therefore additional clinical testing was required.No difficulties were encountered during blood collection and all tubes exhibited proper fill.Bd was unable to duplicate or confirm the customer¿s indicated failure modes (poor barrier separation, poor plasma) because the defect was not evident in the testing of the complaint lot samples.Replicates of both retention and control samples tested demonstrated clinically acceptable performance for all visual observations evaluated.All tubes performed as expected.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 is unable to be confirmed for the indicated failure mode poor barrier separation or poor plasma.Bd was not able to identify a root cause for the indicated failure mode.Complaints received for this device and reported condition will continue to be tracked and trended.Our business team regularly reviews the collected data for identification of emerging trends.

Event Description

It was reported that while using bd vacutainer® cpt¿ nh: ~130 iu ficoll¿: 2.0ml that there was poor barrier separation of sample/ insufficient additive quantity.The following information was provided by the initial reporter: medpace is collecting blood samples from patients and controls.In europe they encounter issues with red blood cell contamination and slanted gel barriers.This is not related to a specific patient group as it can be seen in healthy controls as well.

• 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
• Manufacturer (Section G): BECTON, DICKINSON & CO. (BROKEN BOW); 150 south 1st avenue; broken bow NE 68822
• Manufacturer Contact: jennifer suh ; 5859 farinon drive; san antonio, TX 78249 ; 8448235433
• MDR Report Key: 17671401
• MDR Text Key: 322528472
• Report Number: 1917413-2023-00862
• Device Sequence Number: 1
• Product Code: JCF
• Combination Product (y/n): N
• Reporter Country Code: BE
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 11/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/15/2023
• Initial Date FDA Received: 09/01/2023
• Supplement Dates Manufacturer Received: 11/10/2023
• Supplement Dates FDA Received: 11/27/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1