MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (BROKEN BOW) BD VACUTAINER® ACD SOLUTION A BLOOD COLLECTION TUBES; BLOOD SPECIMEN COLLECTION DEVICE

Model Number 364606

Device Problem Coagulation in Device or Device Ingredient (1096)

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

Event Date 11/09/2021

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® acd solution a blood collection tube there was clotting/micro clots/fibrin clots.This event occurred 16 times.The following information was provided by the initial reporter.The customer stated: there were clot formations in some samples.".

Manufacturer Narrative

H6: investigation summary: bd had not received samples or photos for evaluation.Therefore, retention samples of the incident lot were selected from bd inventory for evaluation and upon completion, no issues relating to clotting were observed.No difficulties were encountered during blood collection and all tubes appeared to exhibit proper fill.Bd was unable to confirm the customer¿s indicated failure (clotting) because the defect was not evident in the testing of the complaint lot samples.Laboratory analysis of customer and control samples 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 is unable to be confirmed for the indicated failure mode clotting.Bd was not able to identify a root cause for the indicated failure mode.

Event Description

It was reported when using the bd vacutainer® acd solution a blood collection tube there was clotting/micro clots/fibrin clots.This event occurred 16 times.The following information was provided by the initial reporter.The customer stated: there were clot formations in some samples.".

• Brand Name: BD VACUTAINER® ACD SOLUTION A BLOOD COLLECTION TUBES
• 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: 13119152
• MDR Text Key: 285015444
• Report Number: 1917413-2021-01092
• Device Sequence Number: 1
• Product Code: JKA
• UDI-Device Identifier: 50382903646062
• UDI-Public: 50382903646062
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: PREAMENDMENT
• 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: 03/10/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/30/2021
• 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: 364606
• Device Catalogue Number: 364606
• Device Lot Number: 1040879
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/10/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/09/2021
• 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