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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON UNSPECIFIED BD 50 ML SYRINGE

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BECTON DICKINSON UNSPECIFIED BD 50 ML SYRINGE Back to Search Results
Catalog Number UNKNOWN
Device Problems Break (1069); Leak/Splash (1354)
Patient Problems High Blood Pressure/ Hypertension (1908); Low Blood Pressure/ Hypotension (1914); Underdose (2542)
Event Date 10/07/2020
Event Type  malfunction  
Manufacturer Narrative
Unknown manufacturer: (b)(4). Date of event: unknown. The date received by manufacturer has been used for this field. Device expiration date: unknown. A device evaluation is anticipated, but has not yet begun. Upon completion of the investigation, a supplemental report will be filed. Device manufacture date: unknown. (b)(4).
 
Event Description
It was reported that an unspecified number of an unspecified bd 50 ml syringe experienced device damage/deformation while still considered operable and a failure to contain blood/medication during use. The following information was provided by the initial reporter: i have been sent details of an incident involving a bd 50ml syringe. The user reported that the patient was on noradrenaline 12mg running at 5ml/hour via pump and suddenly patient become very hypertensive ,so noradrenaline stopped and icu doctor informed. Reviewed by doctor and as per order labetolol infusion started ,few minutes later patient become hypotensive, so restarted noradrenaline 12mg and rate increased to maintain map above 65mmhg and noradrenaline was not responding and patient went in to peri arrest so adrenaline boluses given and adrenaline infusion started. Fluid boluses and albumin given. Abg ,chest x ray ,ecg done and reviewed and decided by doctors to change to a different lumen in cvc line. While changing noradrenaline syringe to a different lumen in cvc spotted dripping from noradrenaline pump and big crack in the syringe by nurse in charge,icu consultants were present at bedside throughout the episodes. Stand by noradrenaline syringe commenced on different lumen in cvc line and blood pressure became stable and patient settled. Informed shift leader , medical team and nursing team at bed side. Syringe pump and broken syringe handed over to shift leaders office for further investigation. Our engineers have checked the pump device with no faults noted but it has been kept in quarantine for the time being along with the syringe.
 
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Brand NameUNSPECIFIED BD 50 ML SYRINGE
Type of DeviceSYRINGE
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
brett wilko
9450 south state street
sandy, UT 84070
8015296192
MDR Report Key10752103
MDR Text Key215365140
Report Number2243072-2020-01755
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
Reporter Country CodeUK
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 12/01/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/28/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue NumberUNKNOWN
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/25/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/30/2020
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

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