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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON, DICKINSON AND COMPANY (BD) BD VACUTAINER® ULTRATOUCH¿ PUSH BUTTON BLOOD COLLECTION SET; BLOOD SPECIMEN COLLECTION DEVICE; INTRAVASCULAR ADMINISTRATION SET
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BECTON, DICKINSON AND COMPANY (BD) BD VACUTAINER® ULTRATOUCH¿ PUSH BUTTON BLOOD COLLECTION SET; BLOOD SPECIMEN COLLECTION DEVICE; INTRAVASCULAR ADMINISTRATION SET Back to Search Results
Catalog Number 367364
Device Problems Product Quality Problem (1506); Difficult or Delayed Activation (2577)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/12/2023
Event Type  malfunction  
Manufacturer Narrative
D.2 medical device type: jka, fpa.H.3.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 while using bd vacutainer® ultratouch¿ push button blood collection set that there was tubing separation or kink, and shield activation issue.The following information was provided by the initial reporter: this report is about tubing failure and needle retraction before use.The customer reported that the tubing was kinked.The needle had already been retracted before use.
 
Event Description
It was reported that while using bd vacutainer® ultratouch¿ push button blood collection set that there was tubing separation or kink, and shield activation issue.The following information was provided by the initial reporter: this report is about tubing failure and needle retraction before use.The customer reported that the tubing was kinked.The needle had already been retracted before use.
 
Manufacturer Narrative
H.6.Investigation summary: bd received 3 samples and 7 photos for investigation.The photos were reviewed and the customer¿s indicated failure modes for kinked tubing and preactivation was observed.The customer samples were evaluated by visual examination and the indicated failure modes for kinked tubing and preactivation with the incident lot were observed.Additionally, 30 retention samples from bd inventory were evaluated by visual examination and the issues of kinked tubing and preactivation were 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.This complaint has been confirmed for the indicated failure modes kinked tubing and preactivation.Bd was not able to identify a root cause for the indicated failure mode.The following fields were updated due to additional information: d9: device available for evaluation:  yes d9: returned to manufacturer on: 2023-08-14.
 
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Brand Name
BD VACUTAINER® ULTRATOUCH¿ PUSH BUTTON BLOOD COLLECTION SET
Type of Device
BLOOD SPECIMEN COLLECTION DEVICE; INTRAVASCULAR ADMINISTRATION SET
Manufacturer (Section D)
BECTON, DICKINSON AND COMPANY (BD)
belliver way
belliver industrial estate
plymouth
UK 
Manufacturer (Section G)
BECTON, DICKINSON AND COMPANY (BD)
belliver way
belliver industrial estate
plymouth
UK  
Manufacturer Contact
jennifer suh
5859 farinon drive
san antonio, TX 78249
8448235433
MDR Report Key17431214
MDR Text Key320172774
Report Number9617032-2023-00999
Device Sequence Number1
Product Code FPA
UDI-Device Identifier50382903673648
UDI-Public(01)50382903673648
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K212724
Number of Events Reported1
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 08/16/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/31/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number367364
Device Lot Number2230228
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Date Manufacturer Received08/16/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/18/2022
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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