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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON, DICKINSON AND COMPANY (BD) BD VACUTAINER® ECLIPSE¿ SIGNAL¿ BLOOD COLLECTION NEEDLE WITH INTEGRATED HOLDER; BLOOD SPECIMEN COLLECTION DEVICE
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BECTON, DICKINSON AND COMPANY (BD) BD VACUTAINER® ECLIPSE¿ SIGNAL¿ BLOOD COLLECTION NEEDLE WITH INTEGRATED HOLDER; BLOOD SPECIMEN COLLECTION DEVICE Back to Search Results
Catalog Number 368836
Device Problem Unsealed Device Packaging (1444)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/02/2022
Event Type  malfunction  
Event Description
It was reported when using the bd vacutainer® eclipse¿ signal¿ blood collection needle with integrated holder device experienced a damaged open unit package / seal where the sterility is compromised.The following information was provided by the initial reporter.The customer stated: this is a report about closure tab separation.According to the customer's report, the closure tab already came off before use.The customer states that this is the third time they had this issue.
 
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.
 
Manufacturer Narrative
The following fields were updated due to additional information: d9: device available for eval yes.D9: returned to manufacturer on: 14-jun-2022.Investigation summary: bd received 1 sample for investigation.The sample was evaluated by visual examination and the indicated failure mode for unit label separation with the incident lot was observed.Additionally, 10 retention samples from bd inventory were evaluated by visual examination and the issue of unit label separation was not observed.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 has been confirmed for the indicated failure mode unit label separation.Bd was not able to identify a root cause for the indicated failure mode.H3 other text : see h10.
 
Event Description
It was reported when using the bd vacutainer® eclipse¿ signal¿ blood collection needle with integrated holder device experienced a damaged open unit package / seal where the sterility is compromised.The following information was provided by the initial reporter.The customer stated: this is a report about closure tab separation.According to the customer's report, the closure tab already came off before use.The customer states that this is the third time they had this issue.
 
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Brand Name
BD VACUTAINER® ECLIPSE¿ SIGNAL¿ BLOOD COLLECTION NEEDLE WITH INTEGRATED HOLDER
Type of Device
BLOOD SPECIMEN COLLECTION DEVICE
Manufacturer (Section D)
BECTON, DICKINSON AND COMPANY (BD)
belliver way
belliver industrial estate
plymouth
UK 
Manufacturer (Section G)
BECTON, DICKINSON AND COMPANY (BD)
belliver way
belliver industrial estate
plymouth
UK  
Manufacturer Contact
phillip emmert
9450 south state street
sandy, UT 84070
8015296192
MDR Report Key14691504
MDR Text Key296600830
Report Number9617032-2022-00546
Device Sequence Number1
Product Code JKA
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
NA
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 06/15/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number368836
Device Lot Number1196362
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 06/02/2022
Initial Date FDA Received06/15/2022
Supplement Dates Manufacturer Received06/15/2022
Supplement Dates FDA Received07/01/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/15/2021
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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