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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON, DICKINSON & CO., (BD) BD VACUTAINER® ECLIPSE¿ BLOOD COLLECTION NEEDLE
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BECTON, DICKINSON & CO., (BD) BD VACUTAINER® ECLIPSE¿ BLOOD COLLECTION NEEDLE Back to Search Results
Catalog Number 368608
Device Problem Leak/Splash (1354)
Patient Problems Blood Loss (2597); No Known Impact Or Consequence To Patient (2692)
Event Date 10/18/2018
Event Type  malfunction  
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 that bd vacutainer® eclipse¿ blood collection needles are sticking in the tubes, and are also spraying blood out into the adaptor.There were multiple instances where the blood sprayed out into the lab.There was no report of exposure to the mucosal membrane, serious injury, or medical intervention.
 
Manufacturer Narrative
Bd had not received samples, but photos were provided by the customer facility for investigation.The photos were evaluated and the customer's indicated failure mode for sleeve fall off and blunt np (non-patient) with the incident lot was 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.Based on evaluation of the customer photos, the customer¿s indicated failure mode for sleeve fall off and blunt np (non-patient) needles with the incident lot was observed.Based on the investigation, the most likely root cause was determined to be related to a manufacturing issue.As a result, bd is reviewing specific areas in the manufacturing process where the cause of this issue may have originated.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored.The bd business team regularly reviews the collected data for identification of emerging trends.
 
Event Description
It was reported that bd vacutainer eclipse blood collection needles are sticking in the tubes, and are also spraying blood out into the adaptor.There were multiple instances where the blood sprayed out into the lab.There was no report of exposure to the mucosal membrane, serious injury, or medical intervention.
 
Manufacturer Narrative
Bd pas received complaints from customers indicating the absence of the bevel on the non-patient (np) needle end of the eclipse blood collection needle product (specifically for catalog# 368608, lot# 8207894) causing blood leakage.Bd is conducting a voluntary medical device recall of a single lot of bd vacutainer® eclipse¿ blood collection needles 22gx1.25 based on confirmed complaints that the bevel is missing from the non-patient (np) needle end of the eclipse blood collection needle.Please reference bd recall #: pas-19-1429-fa, associated with res82351.
 
Event Description
It was reported that bd vacutainer® eclipse¿ blood collection needles are sticking in the tubes, and are also spraying blood out into the adaptor.There were multiple instances where the blood sprayed out into the lab.There was no report of exposure to the mucosal membrane, serious injury, or medical intervention.
 
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Brand Name
BD VACUTAINER® ECLIPSE¿ BLOOD COLLECTION NEEDLE
Type of Device
BLOOD COLLECTION NEEDLE
Manufacturer (Section D)
BECTON, DICKINSON & CO., (BD)
1575 airport road
sumter SC 29153
MDR Report Key8048170
MDR Text Key126511124
Report Number1024879-2018-01354
Device Sequence Number1
Product Code FMI
UDI-Device Identifier50382903686082
UDI-Public50382903686082
Combination Product (y/n)N
PMA/PMN Number
K982541
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,other,user facility
Remedial Action Recall
Type of Report Initial,Followup,Followup
Report Date 03/28/2019
1 Device was Involved in the Event
2 Patient was Involved in the Event
Date FDA Received11/07/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Expiration Date07/31/2023
Device Catalogue Number368608
Device Lot Number8207894
Date Manufacturer Received10/18/2018
Is This a Reprocessed and Reused Single-Use Device? No
Removal/Correction NumberPAS-19-1429-FA
Patient Sequence Number0
Patient Outcome(s) Other;
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