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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 WITH PRE-ATTACHED HOLDER; BLOOD SPECIMEN COLLECTION DEVICE
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BECTON, DICKINSON & CO., (BD) BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET WITH PRE-ATTACHED HOLDER; BLOOD SPECIMEN COLLECTION DEVICE Back to Search Results
Catalog Number 368658
Device Problem Leak/Splash (1354)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 12/10/2019
Event Type  malfunction  
Manufacturer Narrative
Additional medical device type: jka.A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.
 
Event Description
It was reported that bd vacutainer® push button blood collection set with pre-attached holder leaked.This occurred on 5 occasions during use.The following information was provided by the initial reporter: a complaint received by senior opd for five incidents of leakage above the luer connector with pbbcs 23g with different phlebotomists.Visiting the site & checking the lot in use now, pbbcs 23g only available & in use.
 
Event Description
It was reported that bd vacutainer® push button blood collection set with pre-attached holder leaked.This occurred on 5 occasions during use.The following information was provided by the initial reporter: a complaint received by senior opd for five incidents of leakage above the luer connector with pbbcs 23g with different phlebotomists.Visiting the site & checking the lot in use now, pbbcs 23g only available & in use.
 
Manufacturer Narrative
H.6 investigation summary: bd received samples and photos from the customer facility for investigation.The photo provided shows the packaging of the device therefore the customer¿s indicated failure mode for leakage with the incident lot was not observed.Additionally, evaluation/testing of the customer samples was performed, and leakage was not observed.A review of the device history record was completed for the incident lot and, based on this review, all product specifications and requirements for lot release were met; there were no related quality non-conformances during manufacturing of the product.
 
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Brand Name
BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET WITH PRE-ATTACHED HOLDER
Type of Device
BLOOD SPECIMEN COLLECTION DEVICE
Manufacturer (Section D)
BECTON, DICKINSON & CO., (BD)
1575 airport road
sumter SC 29153
MDR Report Key9526302
MDR Text Key181617601
Report Number1024879-2019-02178
Device Sequence Number1
Product Code FMI
Combination Product (y/n)N
PMA/PMN Number
K011984
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,other,user facility
Type of Report Initial,Followup
Report Date 01/30/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/27/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Expiration Date10/31/2020
Device Catalogue Number368658
Device Lot Number8283765
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/24/2019
Date Manufacturer Received12/12/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
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