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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON, DICKINSON & CO., (BD) BD VACUTAINER® ULTRATOUCH¿ PUSH BUTTON BLOOD COLLECTION SET; SEE H.10

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BECTON, DICKINSON & CO., (BD) BD VACUTAINER® ULTRATOUCH¿ PUSH BUTTON BLOOD COLLECTION SET; SEE H.10 Back to Search Results
Catalog Number 367365
Device Problem Difficult or Delayed Activation (2577)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/10/2020
Event Type  malfunction  
Event Description
It was reported that while using bd vacutainer® ultratouch¿ push button blood collection set, customer had 1 retraction issue.This event occurred 1 time and no report of adverse or injury.
 
Manufacturer Narrative
D2: common device name: blood specimen collection device; intravascular administration set d.2.Medical device type: one additional code applies; jka.D4.Medical device expiration date: unknown h4.Device manufacture date: unknown h.3.A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.
 
Manufacturer Narrative
H.6.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.Complaints received for this device and reported condition will continue to be tracked and trended.Our business team regularly reviews the collected data for identification of emerging trends.".
 
Event Description
It was reported that while using bd vacutainer® ultratouch¿ push button blood collection set, customer had 1 retraction issue.This event occurred 1 time and no report of adverse or injury.
 
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Brand Name
BD VACUTAINER® ULTRATOUCH¿ PUSH BUTTON BLOOD COLLECTION SET
Type of Device
SEE H.10
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
jo doyka
7 loveton circle
sparks, MD 21152
4103164000
MDR Report Key18103783
MDR Text Key327755749
Report Number1024879-2023-00802
Device Sequence Number1
Product Code FPA
UDI-Device Identifier00382903673650
UDI-Public(01)00382903673650
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K212724
Number of Events Reported1
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 11/10/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/09/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number367365
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received11/10/2023
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 Number1
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