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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON, S.A. BD EMERALD¿ SYRINGE; PISTON SYRINGE
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BECTON DICKINSON, S.A. BD EMERALD¿ SYRINGE; PISTON SYRINGE Back to Search Results
Catalog Number 303127
Device Problem Tear, Rip or Hole in Device Packaging (2385)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/30/2023
Event Type  malfunction  
Event Description
It was reported that an unspecified number of bd emerald¿ syringes' packaging units ruptured.The following information was provided by the initial reporter, translated from czech: "we have received information from colleagues that the bags are now more prone to rupture and are difficult to handle.Unfortunately, we are now seeing more and more of the bag breaking at the bottom weld, the syringes are contaminated and we can no longer use them.".
 
Manufacturer Narrative
B.3.Date of event: unknown.The date received by manufacturer has been used for this field.H.3.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 an unspecified number of bd emerald¿ syringes' packaging units ruptured.The following information was provided by the initial reporter, translated from czech: "we have received information from colleagues that the bags are now more prone to rupture and are difficult to handle.Unfortunately, we are now seeing more and more of the bag breaking at the bottom weld, the syringes are contaminated and we can no longer use them.".
 
Manufacturer Narrative
After further review, the packaging of the product in question is not considered to be a sterile field.This may lead to customer dissatisfaction but will not lead to harm or serious injury.Therefore, this mdr will be cancelled.
 
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Brand Name
BD EMERALD¿ SYRINGE
Type of Device
PISTON 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
phillip emmert
9450 south state street
sandy, UT 84070
8448235433
MDR Report Key16765754
MDR Text Key313674090
Report Number3002682307-2023-00103
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
Reporter Country CodeEZ
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 05/02/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/18/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number303127
Device Lot Number2298802
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received05/02/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/25/2022
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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