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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL (SINGAPORE) BD VENFLON¿ PRO SAFETY SHIELDED IV CATHETER; INTRAVASCULAR CATHETER
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BECTON DICKINSON MEDICAL (SINGAPORE) BD VENFLON¿ PRO SAFETY SHIELDED IV CATHETER; INTRAVASCULAR CATHETER Back to Search Results
Catalog Number 393224
Device Problem Retraction Problem (1536)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/17/2021
Event Type  malfunction  
Event Description
It was reported that 2 bd venflon¿ pro safety shielded iv catheters experienced a needle that would not disengage.The following information was provided by the initial reporter: patient was acutely unwell and required insertion of a cannula.The cannula was inserted successfully but when the needle was withdrawn to leave the cannula insite, the needle did not retract.The whole unit was removed and she used a different cannula (same product, same lot number) in a different site on the persons body and exactly the same problem occurred.No other harm was caused by this fault, luckily.
 
Manufacturer Narrative
A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
 
Event Description
It was reported that 2 bd venflon¿ pro safety shielded iv catheters experienced a needle that would not disengage.The following information was provided by the initial reporter: patient was acutely unwell and required insertion of a cannula.The cannula was inserted successfully but when the needle was withdrawn to leave the cannula insite, the needle did not retract.The whole unit was removed and she used a different cannula (same product, same lot number) in a different site on the persons body and exactly the same problem occurred.No other harm was caused by this fault, luckily.
 
Manufacturer Narrative
The following fields were updated due to additional information: d9: device available for eval?: yes.D9: returned to manufacturer on: 12/8/2021.H6: investigation: twelve representative samples were received by our quality team for evaluation.The samples were subjected to visual inspection and separation force testing.No abnormalities were observed, and all samples passed the product specification.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.
 
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Brand Name
BD VENFLON¿ PRO SAFETY SHIELDED IV CATHETER
Type of Device
INTRAVASCULAR 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
katie swenson
9450 south state street
sandy, UT 84070
8015296192
MDR Report Key12802526
MDR Text Key281855584
Report Number8041187-2021-00970
Device Sequence Number1
Product Code FOZ
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 Other,Foreign,User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 12/15/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date03/31/2024
Device Catalogue Number393224
Device Lot Number1077700
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/08/2021
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 10/17/2021
Initial Date FDA Received11/12/2021
Supplement Dates Manufacturer Received12/15/2021
Supplement Dates FDA Received01/05/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/27/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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