MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (BROKEN BOW) BD VACUTAINER® SODIUM FLUORIDE: 3 MG. NA2 EDTA; BLOOD SPECIMEN COLLECTION DEVICE

Model Number 367587

Device Problems Break (1069); Device Ingredient or Reagent Problem (2910)

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

Event Date 05/15/2023

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 when using the bd vacutainer® sodium fluoride: 3 mg.Na2 edta: 6mg customer reports small amount of additive, and sticky due to leakage of additive.The following information was provided by the initial reporter.The customer stated: "according to sales rep, customer reported that some of the tubes contained small amount of additive and also felt sticky due to leakage of additive.According to the customer's report, there was a sign that the additive leaked upon unpacking, and a tube with low additive volume was found.".

Event Description

It was reported when using the bd vacutainer® sodium fluoride: 3 mg.Na2 edta: 6mg customer reports small amount of additive, and sticky due to leakage of additive.The following information was provided by the initial reporter.The customer stated: "according to sales rep, customer reported that some of the tubes contained small amount of additive and also felt sticky due to leakage of additive.According to the customer's report, there was a sign that the additive leaked upon unpacking, and a tube with low additive volume was found.".

Manufacturer Narrative

H.6 investigation summary material #: 367587 lot/batch #: 2166013 bd received 44 samples and 8 photos for investigation.The photos were reviewed and the customer¿s indicated failure mode for tray pack residue was observed, however insufficient additive was not observed.Additionally, the customer samples were evaluated by visual examination and the indicated failure mode for tray pack residue with the incident lot was observed, however insufficient additive 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 tray pack residue.This complaint has not been confirmed for the indicated failure mode insufficient additive.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.

• Brand Name: BD VACUTAINER® SODIUM FLUORIDE: 3 MG. NA2 EDTA
• 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 ; 8448235433
• MDR Report Key: 17076559
• MDR Text Key: 316664766
• Report Number: 1917413-2023-00499
• Device Sequence Number: 1
• Product Code: JKA
• UDI-Device Identifier: 50382903675871
• UDI-Public: 50382903675871
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K945952
• 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: 06/12/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/07/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 10/31/2023
• Device Model Number: 367587
• Device Catalogue Number: 367587
• Device Lot Number: 2166013
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/12/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/15/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1