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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
Catalog Number 367363
Device Problem Difficult or Delayed Activation (2577)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/18/2023
Event Type  malfunction  
Event Description
It was reported that while using bd vacutainer® ultratouch¿ push button blood collection set, on two occassions the needle did not fully retract.No date of event is reported.No patient impact reported.The following information was provided by the initial reporter: "on two occasions needle has not fully retracted.This is a safety precaution.No incidents occurred or injury to patient or staff however noted that product did not fully retract.".
 
Manufacturer Narrative
B3: date of event is unknown.The date received by manufacturer has been used for this field.D.2b.Jka.H.6.Investigation summary: material #: 367363.Lot/batch #: 2290433.Bd had not received samples or photos for investigation.Therefore, 30 retention samples from bd inventory were evaluated by functional testing, each having their safety mechanisms activated, and no issues were observed relating to unable to retract as all samples met specifications.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 is unable to be confirmed for the indicated failure mode unable to retract.Bd was not able to identify a root cause for the indicated failure mode.H3 other text : see h.10.
 
Manufacturer Narrative
The following fields have been updated with corrected and/or additional information.D9: device available for evaluation: yes, but sample was from a different lot number (2251212) than the reported lot for this complaint.D9: returned to manufacturer on: 03-oct-2023.H.6.Investigation summary: this complaint is unable to be confirmed.Bd received 1 used sample for investigation.The sample was from a different lot number (2251212) than the reported lot for this complaint.The sample was evaluated by visual examination and the iv cannula was fully retracted so the failure mode for unable to retract was not observed.Additionally, 30 retention samples from bd inventory were evaluated by functional testing, each having their safety feature activated, and no issues were observed relating to unable to retract as all samples met specifications.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 is unable to be confirmed for the indicated failure mode unable to retract.Bd was not able to identify a root cause for the indicated failure mode.Complaints received for this device and reported condition will continue to be tracked and trended.
 
Event Description
It was reported that while using bd vacutainer® ultratouch¿ push button blood collection set, on two occassions the needle did not fully retract.No date of event is reported.No patient impact reported.The following information was provided by the initial reporter: "on two occasions needle has not fully retracted.This is a safety precaution.No incidents occurred or injury to patient or staff however noted that product did not fully retract.
 
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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
jennifer suh
5859 farinon drive
san antonio, TX 78249
8448235433
MDR Report Key17452502
MDR Text Key320393825
Report Number1024879-2023-00531
Device Sequence Number1
Product Code FPA
UDI-Device Identifier50382903673631
UDI-Public50382903673631
Combination Product (y/n)N
Reporter Country CodeUK
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 10/19/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/03/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number367363
Device Lot Number2290433
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Date Manufacturer Received10/19/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/17/2022
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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