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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL (SINGAPORE) VENFLON PRO 20GA 1.1MM OD 32MM L INDIA INTERVASCULAR CATHETER

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BECTON DICKINSON MEDICAL (SINGAPORE) VENFLON PRO 20GA 1.1MM OD 32MM L INDIA INTERVASCULAR CATHETER Back to Search Results
Catalog Number 393234
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Fever (1858); Unspecified Infection (1930)
Event Date 07/20/2020
Event Type  Injury  
Manufacturer Narrative
Investigation summary: one photo was received by our quality team for evaluation. The returned photo shows the top web of the package. The team was unable to confirm the customer experience as no sample was returned. A review of the internal manufacturing device records and raw material history files for the reported lot numbers was performed and no recorded quality problems or rejections to this incident were found. The endotoxins test results for this batch have been reviewed and is within the acceptance criteria. Therefore, the root cause 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. Investigation conclusion: 1 photo was returned for investigation. The photo show the top web with batch #9201066. Unable to confirm the customer experience as no sample was returned. End user risk assessment as per p-eura document, eurap2053015, severity is limited (s2) occurrence
=
(sum of defective samples for all complaints / batch quantity) x 1,000,000
=
((b)(4)) x 1,000,000
=
(b)(4) which is occasional (o3) the risk is acceptable per (b)(4). Root cause description: as no sample and no photo was returned, a review of past 12 months quality notification was performed. No similar quality notification was raised for the reported defect. The endotoxins test results for this batch has been reviewed and it is within the acceptance criteria. Therefore, the root cause cannot be determined. Complaint will be reopened when sample is returned. Rationale: the root cause cannot be determined. Complaint trend would be monitored.
 
Event Description
It was reported that 5 venflon pro 20ga 1. 1mm od 32mm l india were involved with a patient experiencing a systemic infection in the form of a fever. It has not been specified what, if any, additional medical attention/care was received as a result of the fever. The following information was provided by the initial reporter: phlebitis and fever occurs, next day of insertion of cannula, their consumption is 100 units per month , main concern is fever.
 
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Brand NameVENFLON PRO 20GA 1.1MM OD 32MM L INDIA
Type of DeviceINTERVASCULAR 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
8015652341
MDR Report Key10402229
MDR Text Key204083048
Report Number8041187-2020-00484
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Reporter Country CodeIN
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 09/02/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/13/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Expiration Date07/31/2022
Device Catalogue Number393234
Device Lot Number9201066
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/21/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/16/2019
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: 08/13/2020 Patient Sequence Number: 1
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