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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON, DICKINSON & CO., (BD) BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET; BLOOD COLLECTION TUBE
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BECTON, DICKINSON & CO., (BD) BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET; BLOOD COLLECTION TUBE Back to Search Results
Catalog Number 367352
Health Effect - Clinical Code Needle Stick/Puncture (2462)
Date of Event 03/26/2016
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Results: twenty samples were returned for evaluation and tested.All twenty samples were evaluated for iv needle retraction and lockout with no defects identified.A review of the device history record revealed no irregularities during the manufacture of the reported lot # 5343761.Conclusion: bd was not able to duplicate or confirm the customer¿s indicated failure mode.
 
Event or Problem Description
It was reported that during use, a bd vacutainer® push button blood collection set did not retract its needle when the safety was activated.The user was pricked as a result.No medical intervention was reported.
 
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Brand Name
BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET
Common Device Name
BLOOD COLLECTION TUBE
Manufacturer (Section D)
BECTON, DICKINSON & CO., (BD)
1575 airport road
sumter SC 29153
MDR Report Key7059307
Report Number1024879-2017-00315
Device Sequence Number1879852
Product Code JKA
UDI-Device Identifier00382903673520
UDI-Public00382903673520
Combination Product (Y/N)N
Initial Reporter StateMA
Initial Reporter CountryUS
PMA/510(K) Number
K011984
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source other,user facility
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 10/26/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Operator of Device Phlebotomist
Device Expiration Date12/31/2017
Device Catalogue Number367352
Device Lot Number5343761
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/04/2016
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 03/28/2016
Initial Report FDA Received Date11/27/2017
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Outcome Attributed to Adverse Event Other;
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