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

Model Number 367342

Device Problems Break (1069); Leak/Splash (1354)

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

Event Date 03/23/2023

Event Type  malfunction  

Manufacturer Narrative

There were multiple medical device types reported to be involved.The information for the additional device type is as follows: medical device type: fpa.Common device name: intravascular administration set.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 during collection with bd vacutainer® push button blood collection set blood leaked from a break in the tubing.Patient had to be re-drawn.There was no additional impact to patient and no impact to user.The following information was provided by the initial reporter: collector was performing collection on pediatric patient in outpatient setting.Needle had been placed in vein and vacutainer tube was attached.Blood began to seep out of the tubing, not at a connection point but seemingly from a break in the tubing.

Manufacturer Narrative

The following fields were updated due to additional information: d9: device available for evaluation: yes.D9: returned to manufacturer on: 2023-04-17.Material #: [367342].Lot/batch #: [2341563].Bd received [4] samples (1used and 3 unused) and [3] photos for investigation.2 of the 3 photos show a device with damaged tubing.Therefore, this complaint can be confirmed based on the customer photos provided.Bd is able to confirm the customer¿s reported failure mode of leakage based on customer photo analysis.Additionally, the used customer sample was subjected to visual inspection for cut tubing.The sample failed as the tubing was damaged exhibiting a cut.The 3 unused samples were subjected to a draw test to assess for signs of leakage during draw.The samples passed testing exhibiting no defects to the tubing or leakage during use.Therefore, this complaint can be confirmed based on customer sample testing results.Bd is able to confirm the customer¿s reported failure mode of leakage based on customer sample testing analysis.In addition, 30 retain samples were subjected to a draw test to look for any holes in the tubing or signs of leakage.All samples passed testing with no evidence of holes in the tubing or signs of leakage.Therefore, this complaint cannot be confirmed based on retain sample testing results.Bd is unable to confirm the customer¿s reported failure mode of leakage based on retain sample testing analysis.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.Bd was not able to identify a root cause for the indicated failure mode.H3 other text : see h.10.

Event Description

It was reported that during collection with bd vacutainer® push button blood collection set blood leaked from a break in the tubing.Patient had to be re-drawn.There was no additional impact to patient and no impact to user.The following information was provided by the initial reporter: collector was performing collection on pediatric patient in outpatient setting.Needle had been placed in vein and vacutainer tube was attached.Blood began to seep out of the tubing, not at a connection point but seemingly from a break in the tubing.

• Brand Name: BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET
• 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 ; 8448235433
• MDR Report Key: 16753313
• MDR Text Key: 313503455
• Report Number: 1024879-2023-00229
• Device Sequence Number: 1
• Product Code: JKA
• UDI-Device Identifier: 50382903673426
• UDI-Public: (01)50382903673426
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K030573
• 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: 06/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 367342
• Device Catalogue Number: 367342
• Device Lot Number: 2341563
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/27/2023
• Initial Date FDA Received: 04/17/2023
• Supplement Dates Manufacturer Received: 06/21/2023
• Supplement Dates FDA Received: 07/05/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/07/2022
• 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