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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON BD EMERALD¿ SYRINGE
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BECTON DICKINSON BD EMERALD¿ SYRINGE Back to Search Results
Catalog Number 302986
Device Problem Device Contamination with Chemical or Other Material (2944)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 09/28/2021
Event Type  malfunction  
Manufacturer Narrative
Oem manufacture: the manufacturing location for this product is (b)(4).This site is an oem manufacturing site.Therefore, bd corporate headquarters in (b)(4) has been listed and the (b)(4) fda registration number has been used for the manufacture report number.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 the bd emerald¿ syringe experienced foreign matter in the fluid path.The following information was provided by the initial reporter: there seem to be green particles in the syringe.Tiny particles of green material similar to the color of the stopper.
 
Event Description
It was reported that the bd emerald¿ syringe experienced foreign matter in the fluid path.The following information was provided by the initial reporter: there seem to be green particles in the syringe.Tiny particles of green material similar to the color of the stopper.
 
Manufacturer Narrative
H.6 investigation summary: the photo was received by bd for evaluation.A quality engineer was able to review the photo of a emerald 3ml from lot # 0361049 regarding item # 302986 with the reported issue that ¿there seem to be green particles in the syringe.Tiny particles of green material similar to the color of the stopper.¿ the dhr of material number 302986 and lot number 0361049 was checked and no quality notifications were recorded on this lot.No samples and one photograph were received from the customer and were used for investigation of the reported defects.The investigation team also used retention samples of material code 302986 and lot number 0361049 for investigating the reported defect.None of the ten retention samples showed any green like foreign matter in them.The received photograph was investigated for presence of green like foreign matter.The photograph could not confirm or help in identify the green like foreign matter in the sample.The defect is not confirmed.To confirm the defect the original sample will be required.The probable root cause could not be found.Complaints received for this device and reported condition will continue to be tracked and trended.If samples are received in the future the complaint will be reopened for further investigation.No samples and one photograph were received from the customer.The investigation team have used retention samples of material code 302986 and lot number 0361049 for investigating the reported defect of green like foreign matter.Based on the above, no additional investigation and no capa is required at this time.
 
Manufacturer Narrative
The following fields were updated due to additional information: d.9.Device available for eval?: yes.D.9.Returned to manufacturer on: 11/17/2021.H.6.Investigation: the samples were received by bd for evaluation.A quality engineer was able to review the returned samples of (4) emerald 3ml from lot # 0361049 product # 302986 with the reported issue that ¿there seem to be green particles in the syringe.Tiny particles of green material similar to the color of the stopper.¿ the dhr of material number 302986 and lot number 0361049 was checked and no quality notifications were recorded on this lot.Four samples were received from the customer and were used for investigation of the reported defects.The samples are actual and one of them shows the visible defect of contamination with transparent liquid like solidified foreign matter in the fluid path of the syringe.The investigation team has also used retention samples of material code 302986 and lot number 0361049 for investigating the reported defect of green like foreign matter.None of the ten retention samples showed any foreign matter in them.The received samples were investigated for presence of foreign matter.The received sample was sent to a 3rd party lab for testing of foreign matter in the sample.The lab report confirmed the foreign matter to be solidified silicon oil.The defect is confirmed.The silicon oil is used in the manufacturing process in the syringe production.If the machine abruptly stops the silicon oil pump takes a few seconds to synchronize with the machine stoppage and in that interim time a few drops fall into the syringe.H3 other text : see h.10.
 
Event Description
It was reported that the bd emerald¿ syringe experienced foreign matter in the fluid path.The following information was provided by the initial reporter: there seem to be green particles in the syringe.Tiny particles of green material similar to the color of the stopper.
 
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Brand Name
BD EMERALD¿ SYRINGE
Type of Device
SYRINGE
Manufacturer (Section D)
BECTON DICKINSON
1 becton drive
franklin lakes NJ 07417
Manufacturer (Section G)
BECTON DICKINSON
1 becton drive
franklin lakes NJ 07417
Manufacturer Contact
katie swenson
9450 south state street
sandy, UT 84070
8015296192
MDR Report Key12701240
MDR Text Key278621822
Report Number2243072-2021-02590
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
Reporter Country CodeNL
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,Followup
Report Date 12/13/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/26/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number302986
Device Lot Number0361049
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/17/2021
Is the Reporter a Health Professional? Yes
Date Manufacturer Received12/13/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/26/2020
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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