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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 Leak/Splash (1354)
Patient Problem No Code Available (3191)
Event Date 08/15/2019
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.
 
Event Description
It was reported that an unspecified number of syringe 50ml ll experienced difficulty connecting the syringe with the mating component -leakage. The product defect was noted during use. The following information was provided by the initial reporter: the device in question is: sering 50ml ll h850ll (300865), ref: 300865 and serial number: (b)(4). The problem encountered is: "arrival of the patient from the hemodialysis hospitalization service with a heparin syringe pump in progress (syringe pump no. 3 injectomat agilia - unknown serial number / bd plastipak 50 ml syringe ref 300865 - unknown batch number). The heparin syringe pump is disconnected from the patient and connected to the dialysis generator (generator 5008 - fresenius medical care). The dialysis session begins. Patient with a temporary catheter, difficulties at the beginning of the session: many alarms on generator. After 2 hours of dialysis, the dialysis catheter malfunctioned again: pressure alarms + generator pump stops and restarts. After hcw intervention, normalization of suction pressures. Some time later, a "piston head alarm" occurred on syringe pump n°3: the heparin syringe was empty. A new heparin syringe is prepared (bd plastipak 50 ml syringe ref 300865 - lot 1905242) and the syringe pump is changed following the occurrence of this alarm (syringe pump no. 4 - serial number (b)(4)). New malfunction of the catheter dialysis: pressure alarms + generator pump stops and restarts. The hcw is busy setting the alarms of the generator and the catheter, when a "piston head alarm" occurs on syringe pump n°4: the syringe is empty (50 cc passed in less than 2 mn), without any intervention of the ide on the syringe pump between the start and the observation of the empty syringe. The doctor is informed. An injection of antidote to the patient is required. End of the session and return to hospitalization. Heparinemia and anti-xa monitoring in hospital with normalization in 4 hours.
 
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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
brett wilko
9450 south state street
sandy, UT 84070
8015652341
MDR Report Key8975841
MDR Text Key160411296
Report Number3003152976-2019-00609
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
N/A
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other,user facility
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 11/04/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/09/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number300865
Device Lot Number1905242
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/23/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/24/2019
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 09/09/2019 Patient Sequence Number: 1
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