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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL (SINGAPORE) BD VENFLON¿ PRO SAFETY PERIPHERAL SAFETY IV CATHETER INTRAVASCULAR CATHETER

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BECTON DICKINSON MEDICAL (SINGAPORE) BD VENFLON¿ PRO SAFETY PERIPHERAL SAFETY IV CATHETER INTRAVASCULAR CATHETER Back to Search Results
Catalog Number 393224
Device Problem Leak/Splash (1354)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/10/2021
Event Type  malfunction  
Manufacturer Narrative
Investigation summary: one photo was received by our quality team for evaluation. From the photo, a carton label with batch 1176162 was observed. A review of the internal manufacturing device records and raw material history files for the reported lot number was performed and no recorded quality problems or rejections to this incident were found. Based on the quality team's investigation, the root cause of this incident cannot be determined. This incident has been added to our database of reported incidents. Our business team regularly reviews the collected data for identification of emerging trends.
 
Event Description
It was reported that small amounts of anesthesia and blood leaked from the bd venflon¿ pro safety peripheral safety iv catheter injection port during use. The following information was provided by the initial reporter: "leakage from injection-port with the pink cap. Occurrence after patient has been anesthetized they injected and small drips came out from the injection-port. They did think more about that as it was small volumes. Then during the anesthesia, blood flowed from that opening as well. Patient (animal) is unharmed".
 
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Brand NameBD VENFLON¿ PRO SAFETY PERIPHERAL SAFETY IV CATHETER
Type of DeviceINTRAVASCULAR 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
phillip emmert
9450 south state street
sandy, UT 84070
8015296192
MDR Report Key12971969
MDR Text Key285755988
Report Number8041187-2021-01038
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Reporter Country CodeSW
PMA/PMN Number
NA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 11/23/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/09/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number393224
Device Lot Number1176162
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received11/11/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/19/2021
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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