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

Model Number 367812

Device Problems Material Deformation (2976); Separation Problem (4043)

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

Event Date 12/02/2022

Event Type  malfunction  

Event Description

It was reported by the customer that the bd vacutainer® serum blood collection tubes have deformities in the upper part where the stopper is inserted.Verbatim; the tubes with these lot numbers mentioned have deformities in the upper part where the stopper is inserted, it is wider than the diameter of the tube.We estimate that there would be 5 racks of 4.0 ml tubes.We stopped using those tubes that came with these deformities, first because centrifugation was made difficult by having these deformities and the other issue is that the orifice lumen was very small, so in order to use it we had to take serum samples with a needle and syringe, with the risk involved in handling them in this way.

Manufacturer Narrative

Initial reporters email address - (b)(6).A device evaluated by mfr: a device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.

Manufacturer Narrative

The following fields were updated due to additional information: b.5.Describe event or problem: it was reported by the customer that the bd vacutainer® serum blood collection tubes have deformities in the upper part where the stopper is inserted, and the stopper popped off.Each of these events occurred 500 times.Verbatim; the tubes with these lot numbers mentioned have deformities in the upper part where the stopper is inserted, it is wider than the diameter of the tube.We estimate that there would be 5 racks of 4.0 ml tubes.We stopped using those tubes that came with these deformities, first because centrifugation was made difficult by having these deformities and the other issue is that the orifice lumen was very small, so in order to use it we had to take serum samples with a needle and syringe, with the risk involved in handling them in this way.Imdrf annex a grid: a1503.H.6.Investigation summary: bd had not received samples, but 2 photos were provided for investigation.The photos were reviewed and the indicated failure mode for other (damaged) and collapsed tubes were observed.Stopper pop off could not be confirmed via photos.Additionally, 29 retention samples from bd inventory were evaluated by functional testing and upon completion the indicated failure mode for stopper creep out was 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 modes of other (damaged), collapsed tubes , and stopper creep out.Bd has initiated further root cause investigation relating to the issue of serum stopper creep out through corrective and preventive actions.

Event Description

It was reported by the customer that the bd vacutainer® serum blood collection tubes have deformities in the upper part where the stopper is inserted and the stopper popped off.Each of these events occurred 500 times.Verbatim; the tubes with these lot numbers mentioned have deformities in the upper part where the stopper is inserted, it is wider than the diameter of the tube.We estimate that there would be 5 racks of 4.0 ml tubes.We stopped using those tubes that came with these deformities, first because centrifugation was made difficult by having these deformities and the other issue is that the orifice lumen was very small, so in order to use it we had to take serum samples with a needle and syringe, with the risk involved in handling them in this way.

• 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: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 16078131
• MDR Text Key: 308532166
• Report Number: 1024879-2022-00749
• Device Sequence Number: 1
• Product Code: JKA
• Combination Product (y/n): N
• Reporter Country Code: AR
• PMA/PMN Number: BK050036
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/30/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2023
• Device Model Number: 367812
• Device Catalogue Number: 367812
• Device Lot Number: 1354652
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/07/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/20/2021
• 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