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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET; BLOOD SPECIMEN COLLECTION DEVICE
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BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET; BLOOD SPECIMEN COLLECTION DEVICE Back to Search Results
Model Number 367326
Device Problems Premature Activation (1484); Material Split, Cut or Torn (4008)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 09/16/2022
Event Type  malfunction  
Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field there were multiple device types reported to be involved.The information for the additional device types are as follows.Medical device type: jka / fpa.Common device name: blood specimen collection device; intravascular administration set 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, the device experienced failure of the product to contain blood.This event occurred once.The following information was provided by the initial reporter.The customer stated: the customer reported about cut tubing.
 
Manufacturer Narrative
The following fields were updated due to additional information: d9: device available for eval: yes.D9: returned to manufacturer on: 2022-10-12.H6: investigation summary: bd received 1 sample and 4 photos from the customer in support of this complaint for review and analysis.The sample and photos were evaluated and, the issue of cut tubing was observed.Additionally, 30 retention samples from the bd inventory were subjected to a visual test for cut tubing and all of the samples passed exhibiting no cuts or damage to the tubing.Furthermore, the 1 customer sample, along with 100 retention samples, were subjected to a visual test for preactivation and, all the samples passed as there was no evidence of any retracted iv needles.Bd is able to confirm the customer¿s reported failure modes of cut tubing based on the customer sample and photo analysis; however the issue was not observed in the retention sample analysis; however bd is unable to confirm the customer¿s reported failure mode of preactivation based on the customer sample, photo and retention sample analysis.The device history records were reviewed with no issues being identified.There were no related quality notifications.All process and final inspections comply with specification requirements.
 
Event Description
It was reported when using the bd vacutainer® push button blood collection set, the device experienced failure of the product to contain blood.This event occurred once.The following information was provided by the initial reporter.The customer stated: the customer reported about cut tubing.
 
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Brand Name
BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET
Type of Device
BLOOD SPECIMEN COLLECTION DEVICE
Manufacturer (Section D)
BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
9450 south state street
sandy UT 84070
Manufacturer (Section G)
BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
9450 south state street
sandy UT 84070
Manufacturer Contact
phillip emmert
9450 south state street
sandy, UT 84070
8015296192
MDR Report Key15492275
MDR Text Key301031935
Report Number1710034-2022-00553
Device Sequence Number1
Product Code JKA
UDI-Device Identifier50382903673266
UDI-Public50382903673266
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K030573
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 11/08/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/27/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Expiration Date07/31/2023
Device Model Number367326
Device Catalogue Number367326
Device Lot Number1202524
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Date Manufacturer Received11/08/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/21/2021
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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