MAUDE Adverse Event Report: BECTON, DICKINSON & CO., (BD) BD VACUTAINER® SERUM BLOOD COLLECTION TUBES; BLOOD SPECIMEN COLLECTION DEVICE

Catalog Number 367814

Device Problem Break (1069)

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

Event Date 07/20/2023

Event Type  malfunction  

Manufacturer Narrative

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® serum blood collection tubes that there was a cracked tube.The following information was provided by the initial reporter: phase: when the product is in use.Defect; rupture of blood collection tube.Quantity: 1; effects: no other adverse effects on patients.

Manufacturer Narrative

H.6.Investigation summary: material #: 367814.Lot/batch #: 2181492.Bd had not received samples, but 1 photo was provided for investigation.The photo was reviewed and the indicated failure mode for cracked product was observed.Additionally, 30 retention samples from bd inventory were evaluated by visual examination and the issue of cracked product 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 issues during manufacturing of the product.This complaint has been confirmed for the indicated failure mode cracked product.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® serum blood collection tubes that there was a cracked tube.The following information was provided by the initial reporter: phase: when the product is in use.Defect; rupture of blood collection tube.Quantity: (b)(4).Effects: no other adverse effects on patients.

• Brand Name: BD VACUTAINER® SERUM BLOOD COLLECTION TUBES
• Type of Device: BLOOD SPECIMEN COLLECTION DEVICE
• 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: jennifer suh ; 5859 farinon drive; san antonio, TX 78249 ; 8448235433
• MDR Report Key: 17487084
• MDR Text Key: 321144564
• Report Number: 1024879-2023-00549
• Device Sequence Number: 1
• Product Code: JKA
• UDI-Device Identifier: 50382903678148
• UDI-Public: (01)50382903678148
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: BK050036
• 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: 08/30/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/09/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 01/31/2024
• Device Catalogue Number: 367814
• Device Lot Number: 2181492
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/30/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/30/2022
• 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