MAUDE Adverse Event Report: BECTON, DICKINSON AND COMPANY (BD) BD PRESET; TUBES, VIALS, SYSTEMS, SERUM SEPARATORS, BLOOD COLLECTION

Catalog Number 364327

Device Problem Coagulation in Device or Device Ingredient (1096)

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

Event Date 02/18/2024

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 the bd preset that blood coagulation occurred in 2 pieces.No patient impact.

Event Description

It was reported that while using the bd preset that blood coagulation occurred in 2 pieces.No patient impact.

Manufacturer Narrative

The following fields were updated due to additional information: d9: device available for evaluation: yes d.9:device eval by manufacturer? yes d9: returned to manufacturer on: 2024-march- 26th.H.6 investigation summary material #: 364327 lot/batch #: 3137143 bd received 18 samples and 1 photo for investigation.The photo was reviewed and the customer¿s indicated failure mode for clotting was observed.Additionally, ten of the customer samples along with 10 retention samples from bd inventory were evaluated for their heparin content and the indicated failure mode for clotting with the incident lot 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 clotting.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.

• Brand Name: BD PRESET
• Type of Device: TUBES, VIALS, SYSTEMS, SERUM SEPARATORS, BLOOD COLLECTION
• Manufacturer (Section D): BECTON, DICKINSON AND COMPANY (BD); belliver way; belliver industrial estate; plymouth ; UK
• Manufacturer (Section G): BECTON, DICKINSON AND COMPANY (BD); belliver way; belliver industrial estate; plymouth ; UK
• Manufacturer Contact: jo doyka ; 7 loveton circle; sparks, MD 21152 ; 4103164000
• MDR Report Key: 19000271
• MDR Text Key: 339016948
• Report Number: 9617032-2024-00458
• Device Sequence Number: 1
• Product Code: JKA
• UDI-Device Identifier: 50382903643276
• UDI-Public: (01)50382903643276
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: NA
• 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: 04/05/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/28/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 364327
• Device Lot Number: 3137143
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/05/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/17/2023
• 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