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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 Free or Unrestricted Flow (2945)
Patient Problems Air Embolism (1697); Coma (2417)
Event Date 05/19/2021
Event Type  Injury  
Manufacturer Narrative
Medical device expiration date: unknown. A device evaluation and/or device history review is anticipated, but is not complete. Upon completion, a supplemental report will be filed. Device manufacture date: unknown.
 
Event Description
It was reported that syringe 50ml ll had air in the line. The following information was provided by the initial reporter: cerebral gas embolism related to a defective syringe that allowed air to enter the central venous catheter. It was during a report one month later for a propofol syringe found with air that we understood the cause of the embolism. Clinical consequences and current status of the patient or person involved: abrupt coma secondary to gas embolism ct scan shows distal pneumo-encephaly in favor of gas embolism. Tracheotomy and prolongation of the stay in the medical intensive care unit severe neurological damage including tetraparesis and mixed aphasia. Discharged on (b)(6) to the geriatric ward. Actions taken for the patient vis-à-vis the dm: emergency hyperbaric oxygen therapy. Information for the family and the patient. For the 1st incident (nacl syringe), there was a gas embolism and the syringe is suspected but an investigation is underway on your side? the gas embolism was diagnosed on the scanner (presence of several air bubbles in the brain), the whole team is looking for the cause of this embolism. At the meeting, we retraced the events to try to understand, but the only malfunction found was the syringe with air found when preparing the patient for transfer to the hyperbaric chamber. To date, the patient has motor sequelae due to cerebral ischemia caused by the gas embolism (+ prolonged stay).
 
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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 Key12186140
MDR Text Key264847820
Report Number3003152976-2021-00400
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 foreign,other,user facility
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 08/04/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/17/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number300865
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/29/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/04/2021
Was Device Evaluated by Manufacturer? Yes
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: 07/17/2021 Patient Sequence Number: 1
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