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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; BLOOD SPECIMEN COLLECTION DEVICE; INTRAVASCULAR ADMINISTRATION SET
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BECTON, DICKINSON & CO., (BD) BD VACUTAINER® ULTRATOUCH¿ PUSH BUTTON BLOOD COLLECTION SET; BLOOD SPECIMEN COLLECTION DEVICE; INTRAVASCULAR ADMINISTRATION SET Back to Search Results
Model Number 367364
Device Problem Device Damaged Prior to Use (2284)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/27/2022
Event Type  malfunction  
Manufacturer Narrative
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 that bd vacutainer® ultratouch¿ push button blood collection set has holes in tubes.The following information was provided by the initial reporter.The customer stated: customer states product tubing has holes.This product is faulty, with some units having holes in the plastic tubing.This is a safety concern for both patient and employee, as this could cause blood leakage/spillage.
 
Manufacturer Narrative
The following fields have been updated with additional information: d.4.Medical device lot #: 1347947.D.4.Medical device expiration date: 31-aug-2023.D.9.Device available for eval? yes.D.9 returned to manufacturer on: 31-aug-2022.H.4.Device manufacture date: 13-dec-2021.H.6.Investigation summary: bd received 5 samples and 1 photo for investigation.The photo and samples were reviewed and the indicated failure mode for damaged/ cut tubing was observed.Additionally, 17 retention samples from bd inventory, were evaluated by visual examination and functional testing and upon completion the indicated failure mode for damaged/ cut tubing 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.This complaint has been confirmed for the indicated failure mode damaged/ cut tubing.Bd has initiated further root cause investigation relating to the issue of damaged/ cut tubing through corrective and preventive actions.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 bd vacutainer® ultratouch¿ push button blood collection set has holes in tubes.The following information was provided by the initial reporter.The customer stated: customer states product tubing has holes.This product is faulty, with some units having holes in the plastic tubing.This is a safety concern for both patient and employee, as this could cause blood leakage/spillage.
 
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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 & 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 Key14992916
MDR Text Key302829425
Report Number1024879-2022-00360
Device Sequence Number1
Product Code FPA
UDI-Device Identifier50382903673648
UDI-Public50382903673648
Combination Product (y/n)N
Reporter Country CodeCA
PMA/PMN Number
K153309
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 09/09/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/12/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Expiration Date12/31/2023
Device Model Number367364
Device Catalogue Number367364
Device Lot Number1347947
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Date Manufacturer Received09/09/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/13/2021
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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