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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL (SINGAPORE) BD NEOFLON¿ IV CANNULA SYSTEM 24 G X 1 IN. INTRAVENOUS CATHETER

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BECTON DICKINSON MEDICAL (SINGAPORE) BD NEOFLON¿ IV CANNULA SYSTEM 24 G X 1 IN. INTRAVENOUS CATHETER Back to Search Results
Catalog Number 391350
Device Problem Difficult to Insert (1316)
Patient Problem Hypoglycemia (1912)
Event Date 09/07/2017
Event Type  Injury  
Manufacturer Narrative
No return sample for investigation. The nonconformance cannot be confirmed as no sample was returned for investigation. Thus, no root cause can be determined. The complaint will be re-opened if the sample is returned for investigation. A review of the device history record revealed no irregularities during the manufacture of the reported lot # 7076167. A manufacturing review also revealed no abnormalities that could have influenced the reported issue. Capa # (b)(4) was issued to review the tubing material.
 
Manufacturer Narrative
(b)(6). A device evaluation is anticipated, but has not yet begun. Upon completion of the investigation, a supplemental report will be filed. (b)(4).
 
Event Description
It was reported that during use, the neonatal medical team was not able to place a cannula due to difficult cannula insertion. The baby¿s blood glucose dropped to an unsafe level during attempts. The infant who was involved in this incident will be followed up as an outpatient to determine the effects of this incident with low blood glucose. A bolus of dextrose was administered as medical intervention.
 
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Brand NameBD NEOFLON¿ IV CANNULA SYSTEM 24 G X 1 IN.
Type of DeviceINTRAVENOUS CATHETER
Manufacturer (Section D)
BECTON DICKINSON MEDICAL (SINGAPORE)
30 tuas avenue 2
singapore
Manufacturer (Section G)
BECTON DICKINSON MEDICAL (SINGAPORE)
30 tuas avenue 2
singapore
Manufacturer Contact
brett wilko
9450 south state street
sandy, UT 84070
8015652845
MDR Report Key6907608
MDR Text Key250301007
Report Number8041187-2017-00121
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Reporter Country CodeUK
PMA/PMN Number
K850276
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,o
Reporter Occupation
Type of Report Initial,Followup
Report Date 10/20/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/02/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date02/28/2022
Device Catalogue Number391350
Device Lot Number7076167
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 Received09/07/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/13/2017
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: 10/02/2017 Patient Sequence Number: 1
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