MAUDE Adverse Event Report: BECTON, DICKINSON AND COMPANY (BD) BD VACUTAINER® K3 EDTA / APROTININ TUBE; BLOOD SPECIMEN COLLECTION DEVICE

Catalog Number 361017

Device Problem Fracture (1260)

Patient Problem Exposure to Body Fluids (1745)

Event Date 07/17/2023

Event Type  malfunction  

Event Description

It was reported when using the bd vacutainer® k3 edta / aprotinin tube customer reports the glass breaks easily.The following information was provided by the initial reporter.The customer stated: "the glass tube breaks very easily.".

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.B.3.Date of event: unknown.The date received by manufacturer has been used for this field.E.1.Initial reporter phone # : (b)(6).

Manufacturer Narrative

H.6.Investigation summary: bd received 23 samples for investigation.The samples were evaluated by visual examination and the indicated failure mode for glass breakage with the incident lot was not observed as all product specifications were met.Additionally, 10 of the returned tubes were drawn with water and none of the tubes broke.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 glass breakage.The following fields were updated due to additional information: d9: device available for evaluation:  yes d9: returned to manufacturer on: 2023-08-16.

Event Description

It was reported when using the bd vacutainer® k3 edta / aprotinin tube customer reports the glass breaks easily.The following information was provided by the initial reporter.The customer stated: "the glass tube breaks very easily.".

• Brand Name: BD VACUTAINER® K3 EDTA / APROTININ TUBE
• Type of Device: BLOOD SPECIMEN COLLECTION DEVICE
• 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: jennifer suh ; 9450 south state street; sandy, UT 84070 ; 8448235433
• MDR Report Key: 17472218
• MDR Text Key: 320524174
• Report Number: 9617032-2023-01051
• Device Sequence Number: 1
• Product Code: JKA
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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: 08/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/07/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 12/31/2023
• Device Catalogue Number: 361017
• Device Lot Number: 2350832
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/17/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/16/2022
• 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