MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (BROKEN BOW) BD VACUTAINER® CPT¿ CELL PREPARATION TUBE WITH SODIUM CITRATE; BLOOD SPECIMEN COLLECTION DEVICE

Model Number 362760

Device Problem Device Ingredient or Reagent Problem (2910)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/30/2022

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 when using the bd vacutainer® cpt¿ cell preparation tube with sodium citrate, the customer reports that the gel is not separating with initial spin.The following information was provided by the initial reporter.The customer stated: customer reports that the gel is not separating with initial spin, additional spin is required to get the gel to separate correctly for item 362760.This happens the gel is not separating with initial spin, additional spin is required to get the gel to separate correctly.

Event Description

It was reported when using the bd vacutainer® cpt¿ cell preparation tube with sodium citrate, the customer reports that the gel is not separating with initial spin.The following information was provided by the initial reporter.The customer stated: customer reports that the gel is not separating with initial spin, additional spin is required to get the gel to separate correctly for item 362760.This happens the gel is not separating with initial spin, additional spin is required to get the gel to separate correctly.

Manufacturer Narrative

H.6.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 separation was observed.Additionally, retention samples of the incident lot were selected from bd inventory for evaluation and upon completion, the indicated failure mode for poor barrier separation was not observed.No difficulties were encountered during blood collection and all tubes exhibited proper fill.Bd was unable to duplicate the customer¿s indicated failure (poor barrier) 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 has been confirmed for the indicated failure mode poor barrier separation based on photos only.Bd was not able to identify a root cause for the indicated failure mode.

• Brand Name: BD VACUTAINER® CPT¿ CELL PREPARATION TUBE WITH SODIUM CITRATE
• 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: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 16064630
• MDR Text Key: 306840375
• Report Number: 1917413-2022-00815
• Device Sequence Number: 1
• Product Code: JKA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K911731
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 02/16/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 02/28/2023
• Device Model Number: 362760
• Device Catalogue Number: 362760
• Device Lot Number: 2054828
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/16/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/23/2022
• 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