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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON, S.A. SYRINGE 50ML LL

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BECTON DICKINSON, S.A. SYRINGE 50ML LL Back to Search Results
Catalog Number 300865
Device Problem Break (1069)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 08/16/2021
Event Type  malfunction  
Manufacturer Narrative
A device evaluation and/or device history review is anticipated, but is not complete. Upon completion, a supplemental report will be filed.
 
Event Description
It was reported that syringe 50ml ll tip broke off. This occurred on 4 occasions. The following information was provided by the initial reporter: in order to administer feiba®, the syringe becomes defective. We attach a bd luer-lok 50 ml syringe onto the feiba vial (baxject ii hi-flow device) to withdraw the reconstituted medicine into the syringe. We have now experienced four times that the tip of the syringe breaks off and settles in the device. The medicine, which costs between dkk 20,000 and 60,000, is lost. We normally have no problems with this. The customer explains further: the medication is to be used with a syringe pump. They have used bd plastipak for several years for this procedure without any issues. They use 3 vials (20,000 dkk each) for each procedure so they withdraw the medication 3 times in the same syringe. They have since the incidences in last week been very careful not to tighten the luer-lock syringe too hard. They only use 300865 for this procedure in the ward. The incidence has happened twice last week and twice this week. They have discarded all used products and there are no syringes left from the affected lot number.
 
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Brand NameSYRINGE 50ML LL
Type of DeviceSYRINGE
Manufacturer (Section D)
BECTON DICKINSON, S.A.
camino de valdeolivia
s/n
san agustin de guadalix
Manufacturer (Section G)
BECTON DICKINSON, S.A.
camino de valdeolivia
s/n
san agustin de guadalix
Manufacturer Contact
katie swenson
9450 south state street
sandy, UT 84070
8015296192
MDR Report Key12502424
MDR Text Key272721089
Report Number3003152976-2021-00613
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
Reporter Country CodeDA
PMA/PMN Number
NA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,other,user facility
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 10/06/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/20/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number300865
Device Lot Number2012010
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/06/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured12/02/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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