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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON, S.A. BD EMERALD¿ 2ML SYRINGE

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BECTON DICKINSON, S.A. BD EMERALD¿ 2ML SYRINGE Back to Search Results
Catalog Number 307727
Device Problem Leak/Splash (1354)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/10/2021
Event Type  malfunction  
Manufacturer Narrative
A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.There were multiple lot numbers reported to be involved.The information for each lot number is as follows: medical device lot #: 2103129.Medical device expiration date: 2026-02-28.Device manufacture date: 2021-03-01.Medical device lot #: 103277 medical device expiration date: 2026-02-28.Device manufacture date: 2021-03-22.
 
Event Description
It was reported that 2 bd emerald¿ 2ml syringes experienced damaged syringe tips.The following information was provided by the initial reporter: during the administration of the radiopharmaceutical, a drop of blood appeared on the pad (this is abnormal because once the syringe has been connected to the tubing, there should be no leakage).The administration of the drug was stopped and the residual activity in the syringe was checked: only 20% of the initially planned activity has been administered (147 mbq out of the 750 mbq).(147 mbq out of the 750mbq) no team member had direct contact with blood or the product used.The leak is difficult to see with the naked eye, but appears to be a physical defect in the syringe: the chip is about 1mm in size and is located on the end of the syringe.
 
Event Description
It was reported that 2 bd emerald¿ 2ml syringes experienced damaged syringe tips.The following information was provided by the initial reporter: during the administration of the radiopharmaceutical, a drop of blood appeared on the pad (this is abnormal because once the syringe has been connected to the tubing, there should be no leakage).The administration of the drug was stopped and the residual activity in the syringe was checked: only 20% of the initially planned activity has been administered (147 mbq out of the 750 mbq).(147 mbq out of the 750mbq) no team member had direct contact with blood or the product used.The leak is difficult to see with the naked eye, but appears to be a physical defect in the syringe: the chip is about 1mm in size and is located on the end of the syringe.
 
Manufacturer Narrative
H.6.Investigation: a complaint of damage found on a syringe causing leakage was received by the customer.This is the 1st complaint for leakage on material 300727 and batch 2103129.No photos or samples were returned by the customer.A device history record review was completed by our quality engineer team for provided lot number 2103277.The review did not reveal any detected abnormalities during the production process that could have contributed to this defect and all quality tests were found to be within specification.As a sample was unavailable for return, a thorough sample investigation could not be completed.Based on the investigation results, an exact cause for this incident could not be identified.
 
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Brand Name
BD EMERALD¿ 2ML SYRINGE
Type of Device
SYRINGE
Manufacturer (Section D)
BECTON DICKINSON, S.A.
cr mequinenza
s/n
fraga, huesca 22520
SP  22520
Manufacturer (Section G)
BECTON DICKINSON, S.A.
cr mequinenza
s/n
fraga, huesca 22520
SP   22520
Manufacturer Contact
katie swenson
9450 south state street
sandy, UT 84070
8015296192
MDR Report Key12650566
MDR Text Key277248465
Report Number3002682307-2021-00557
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
NA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,Distributor
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 11/03/2021
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 Number307727
Device Lot Number2103277
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 09/20/2021
Initial Date FDA Received10/18/2021
Supplement Dates Manufacturer Received11/03/2021
Supplement Dates FDA Received11/29/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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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