MAUDE Adverse Event Report: BECTON, DICKINSON & CO., (BD) BD VACUTAINER® BULK GEL; CPT GEL

Catalog Number 368586

Device Problem Device Contamination with Chemical or Other Material (2944)

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

Event Date 04/26/2022

Event Type  malfunction  

Event Description

It was reported when using the bd vacutainer® bulk gel there was foreign matter in the tube(s) biological and non-biological.The following information was provided by the initial reporter.The customer stated: "the pail of gel is contaminated.".

Manufacturer Narrative

Date of event: unknown.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Manufacturer Narrative

The following fields were updated due to additional information: d9.Device available for evaluation? yes; d9.Returned to manufacturer on: 05/04/2022.H.6.Investigation summary: catalog number: 368586; batch number: 2017217.Bd received 1 sample and 3 photos for investigation.The photos were reviewed and the customer¿s indicated failure mode for foreign matter was observed.Additionally, the customer samples were evaluated by visual examination and the indicated failure mode for foreign matter with the incident lot was 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 issues during manufacturing of the product.This complaint has been confirmed for the indicated failure mode foreign matter.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.H3 other text : see h10.

Event Description

It was reported when using the bd vacutainer® bulk gel there was foreign matter in the tube(s) biological and non-biological.The following information was provided by the initial reporter.The customer stated: "the pail of gel is contaminated.".

• Brand Name: BD VACUTAINER® BULK GEL
• Type of Device: CPT GEL
• Manufacturer (Section D): BECTON, DICKINSON & CO., (BD); 1575 airport road; sumter SC 29153
• Manufacturer (Section G): BECTON, DICKINSON & CO., (BD); 1575 airport road; sumter SC 29153
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 14291506
• MDR Text Key: 295808828
• Report Number: 1024879-2022-00260
• Device Sequence Number: 1
• Product Code: JCF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: NA
• 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: 08/17/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/05/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 04/21/2022
• Device Catalogue Number: 368586
• Device Lot Number: 2017217
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/17/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/17/2022
• 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