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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
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BECTON, DICKINSON & CO., (BD) BD VACUTAINER® ULTRATOUCH¿ PUSH BUTTON BLOOD COLLECTION SET; BLOOD SPECIMEN COLLECTION DEVICE Back to Search Results
Model Number 367364
Device Problem Material Fragmentation (1261)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 05/24/2022
Event Type  malfunction  
Event Description
It was reported when using the bd vacutainer® ultratouch¿ push button blood collection set was found kinked.The following information was provided by the initial reporter.The customer stated: ¿the customer reported about a kinked tubing of wingset utpbbcs.The lot# is being confirmed and will be updated.¿.
 
Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.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® ultratouch¿ push button blood collection set was found kinked.The following information was provided by the initial reporter.The customer stated: ¿the customer reported about a kinked tubing of wingset utpbbcs.The lot # is being confirmed and will be updated.¿.
 
Manufacturer Narrative
The following fields have been updated with additional information: d.4 medical device lot #1228668, d.4.Medical device expiration date: 31-aug-2023, h.4.Device manufacture date: 16-aug-2021.D.9.Device available for eval? yes, d.9.Returned to manufacturer on: 06-jun-2022.H.6 investigation summary: 1 physical sample as well as 3 photos were received from the customer for review and analysis.The photos and sample were evaluated and the issue of preactivation was observed.Bd is able to confirm the customer¿s reported failure from the photos and sample received.The root cause of the kinked tubing would be preactivation of the iv needle in the package as this would cause the tubing to push down against the bottom of the blister pack.A definite root cause of the preactivation could not be determined.The device history records were reviewed with no issues being identified.There were no related quality notifications and all process and final inspections comply with specification requirements.Based on a review of batch records, no root cause from manufacturing was identified as a contributor.Based on an evaluation of severity and frequency it was determined that no corrective action is required at this time.
 
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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 Key14575423
MDR Text Key293177207
Report Number1024879-2022-00286
Device Sequence Number1
Product Code FPA
UDI-Device Identifier50382903673648
UDI-Public50382903673648
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K153309
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 08/29/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/02/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Expiration Date08/31/2023
Device Model Number367364
Device Catalogue Number367364
Device Lot Number1228668
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Date Manufacturer Received08/29/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/16/2021
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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