• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

BECTON DICKINSON MEDICAL (SINGAPORE) BD VENFLON¿ PRO SAFETY PERIPHERAL SAFETY IV CATHETER SAFETY PORTED CATHETER Back to Search Results
Catalog Number 393226
Device Problems Unsealed Device Packaging (1444); Device Packaging Compromised (2916)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 11/17/2017
Event Type  malfunction  
Manufacturer Narrative
Investigation summary: no sample and no photo was returned for the investigation of this complaint. Investigation conclusion: no sample and no photo was returned for investigation. Root cause description: the root cause cannot be determined as there is no sample and no photo returned. There is no process in the manufacturing facility that could cause this nonconformance. There was 100% sorting done on sterile parts for this affected batch prior to shipment. Based on the above investigation result, the reported nonconformance occurred after the product was packed in our manufacturing and sterilization process. Therefore, the probable root cause could be due to temperature gradient experience by the product during handling (transportation, storage, loading and unloading, etc. ) dhr- reviewed lot master for batch #7207496. No related qn issued for this batch.
 
Event Description
It was reported that before use, a bd venflon¿ pro safety peripheral safety iv catheter package was found open. ¿it looks like the plastic is exposed to high heat. ¿ there was no report of injury or medical intervention needed.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameBD VENFLON¿ PRO SAFETY PERIPHERAL SAFETY IV CATHETER
Type of DeviceSAFETY PORTED 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 Key7113213
MDR Text Key95079465
Report Number8041187-2017-00245
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Reporter Country CodeSW
PMA/PMN Number
N/A
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,other,user facility
Reporter Occupation
Type of Report Initial
Report Date 11/28/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/13/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Expiration Date07/31/2020
Device Catalogue Number393226
Device Lot Number7207496
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/21/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/18/2017
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: 12/13/2017 Patient Sequence Number: 1
-
-