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

Model Number 367364

Device Problems Fluid/Blood Leak (1250); Short Fill (1575)

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

Event Date 12/02/2021

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.There were multiple medical device types reported to be involved.The information for each 510(k) number is as follows: common device name: intravascular administration set.Medical device type: fpa.Medical device expiration date: unknown.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.

Event Description

It was reported when using the bd vacutainer® ultratouch¿ push button blood collection set there was insufficient blood flow through the device and blood splatter/leakage or other sample leakage from the device other than the insertion site or needle tip.The following information was provided by the initial reporter.It was reported by the customer there were multiple issue with the wingset.The customer stated: "since using the new butterflies we collectively have experienced issues.We have seen the blood not flow or flow outside of the needle.We have noticed that it is not the tubes, it is an issue with the new butterflies.".

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.There were multiple medical device types reported to be involved.The information for each 510(k) number is as follows: common device name: intravascular administration set.Medical device type: fpa.Medical device expiration date: unknown.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.

Event Description

It was reported when using the bd vacutainer® ultratouch¿ push button blood collection set there was insufficient blood flow through the device and blood splatter/leakage or other sample leakage from the device other than the insertion site or needle tip.The following information was provided by the initial reporter.It was reported by the customer there were multiple issue with the wingset.The customer stated: "since using the new butterflies we collectively have experienced issues.We have seen the blood not flow or flow outside of the needle.We have noticed that it is not the tubes, it is an issue with the new butterflies.".

Manufacturer Narrative

H6: investigation summary bd had not received samples or photos for evaluation.Additionally, bd was unable to determine the specific lot number associated with this complaint; therefore, a review of the device history record could not be conducted.This complaint is unable to be confirmed.If additional information is made available, this complaint will be reopened to assess the level of investigation needed.H3 other text : see h10.

Event Description

It was reported when using the bd vacutainer® ultratouch¿ push button blood collection set there was insufficient blood flow through the device and blood splatter/leakage or other sample leakage from the device other than the insertion site or needle tip.The following information was provided by the initial reporter.It was reported by the customer there were multiple issue with the wingset.The customer stated: "since using the new butterflies we collectively have experienced issues.We have seen the blood not flow or flow outside of the needle.We have noticed that it is not the tubes, it is an issue with the new butterflies.".

• Brand Name: BD VACUTAINER® ULTRATOUCH¿ 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: 13114498
• MDR Text Key: 285747533
• Report Number: 1024879-2021-00888
• Device Sequence Number: 1
• Product Code: JKA
• UDI-Device Identifier: 50382903673648
• UDI-Public: 50382903673648
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K153309
• 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
• Report Date: 01/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/29/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 367364
• Device Catalogue Number: 367364
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/11/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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