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

Model Number 367342

Device Problem Material Puncture/Hole (1504)

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

Event Date 04/06/2022

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.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® push button blood collection set there was failure of product to contain blood/medication.This event occurred 4 times.The following information was provided by the initial reporter.The customer stated: 'the needle has hole in it.Blood was taking a while to fill the tube.There was a drop of blood building up on the butterfly tube connecting to the vacutainer.After inspecting a second device the needle was found with another hole on the tube.Three more had holes on the tubes.The fourth one had a good needle equipment for the patient.".

Event Description

It was reported when using the bd vacutainer® push button blood collection set there was failure of product to contain blood/medication.This event occurred 4 times.The following information was provided by the initial reporter.The customer stated: 'the needle has hole in it.Blood was taking a while to fill the tube.There was a drop of blood building up on the butterfly tube connecting to the vacutainer.After inspecting a second device the needle was found with another hole on the tube.Three more had holes on the tubes.The fourth one had a good needle equipment for the patient.".

Manufacturer Narrative

Investigation summary.Bd did not receive samples or photographs from the customer in support of this complaint.Retained samples could not be tested because the lot number was not provided.Bd was unable to duplicate or confirm the customer¿s indicated failure mode.Bd was not able to identify a root cause for the indicated failure mode.The device history records could not be reviewed because lot number was not provided.

Manufacturer Narrative

The following fields have been changed capturing the additional information provided.D.4.Medical device lot #: 0301741.D.4.Medical device expiration date: 2022-10-31.D9: device available for eval yes.D9: returned to manufacturer on: 2022-05-24.Device manufacture date: 2020-10-27.H.6.Investigation summary: catalog number: 367342.Batch number: 0301741 bd received 20 samples for investigation.The samples were evaluated by functional testing and the indicated failure mode for hole in tubing 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.While bd was unable to confirm this complaint for the indicated failure mode hole in tubing, bd has initiated further root cause investigation relating to the issue of hole in tubing through corrective and preventive actions.Our business team regularly reviews the collected data for identification of emerging trends.

Event Description

It was reported when using the bd vacutainer® push button blood collection set there was failure of product to contain blood/medication.This event occurred 4 times.The following information was provided by the initial reporter.The customer stated: 'the needle has hole in it.Blood was taking a while to fill the tube.There was a drop of blood building up on the butterfly tube connecting to the vacutainer.After inspecting a second device the needle was found with another hole on the tube.Three more had holes on the tubes.The fourth one had a good needle equipment for the patient.".

• 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 ; 8015296192
• MDR Report Key: 14149050
• MDR Text Key: 289760513
• Report Number: 1024879-2022-00234
• Device Sequence Number: 1
• Product Code: JKA
• UDI-Device Identifier: 50382903673426
• UDI-Public: 50382903673426
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K030573
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 07/25/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/19/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 10/31/2022
• Device Model Number: 367342
• Device Catalogue Number: 367342
• Device Lot Number: 0301741
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/25/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/01/2021
• 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
• Patient Age: 86 YR