MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (BROKEN BOW) BD VACUTAINER® CPT¿ NH FICOLL¿; BLOOD SPECIMEN COLLECTION DEVICE

Catalog Number 362780

Device Problem Break (1069)

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

Event Date 11/20/2021

Event Type  malfunction  

Manufacturer Narrative

Investigation summary: bd had not received samples, but one (1) photo was provided for investigation.The photo was reviewed and the indicated failure mode for glass breakage during centrifugation was observed, as the photo shows broken tubes in the centrifuge.Additionally, twenty-three (23) retention samples from bd inventory were evaluated by visual examination and the issue of glass breakage was not observed.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 notifications.This complaint has been confirmed for the indicated failure mode of glass breakage during centrifugation based on the photo provided.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 the bd vacutainer® cpt¿ nh ficoll¿ glass tube broke during the centrifugation.The following information was provided by the initial reporter: "tubes centrifuged at 1800g for 30min following ifu.Sometimes during centrifugation, the tubes break"."tube breakage during centrifugation incident happened: during use".

• 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
• 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: 13061378
• MDR Text Key: 285014393
• Report Number: 1917413-2021-01079
• Device Sequence Number: 1
• Product Code: JCF
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K891407
• 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
• Report Date: 11/29/2021

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 Expiration Date: 11/30/2021
• Device Catalogue Number: 362780
• Device Lot Number: 0311203
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/29/2021
• Initial Date FDA Received: 12/22/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/06/2020
• 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