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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL (SINGAPORE) BD CATHENA¿ SAFETY IV CATHETER WITH BD MULTIGUARD¿ TECHNOLOGY; INTRAVASCULAR CATHETER
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BECTON DICKINSON MEDICAL (SINGAPORE) BD CATHENA¿ SAFETY IV CATHETER WITH BD MULTIGUARD¿ TECHNOLOGY; INTRAVASCULAR CATHETER Back to Search Results
Model Number 386807
Device Problem Leak/Splash (1354)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/10/2021
Event Type  malfunction  
Event Description
It was reported when using the bd cathena¿ safety iv catheter with bd multiguard¿ technology there was leakage at the catheter and hub junction.The following information was provided by the initial reporter.The customer stated: "after catheter placement, the infusion was started and leakage was then observed.When the hcp checked the product, the leakage was occurring around the area between the catheter and the catheter hub.".
 
Manufacturer Narrative
Medical device expiration date: unknown.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.
 
Manufacturer Narrative
H6: investigation summary three photos and two samples, one actual and one representative without packaging, were received by our quality team for evaluation.From the photos, leakage was observed at the end of the catheter tubing near the nose of the adapter.Both samples were subjected to the catheter leak test.The actual sample failed the leak test by leaking at the end of the catheter tubing near the nose of the adapter, while the representative sample passed.The actual sample was subjected to visual inspection for tubing damage.Two cuts were observed near the nose of the adapter.A device history record could not be evaluated as the lot number is unknown.The assembly process was reviewed, there is no station that has contact with the catheter tubing at this location which will cause the observed cuts on the catheter tubing.The cuts could be caused when the product was manipulated during product application.As the sample has been used, the actual root cause could not be established.H3 other text : see h10.
 
Event Description
It was reported when using the bd cathena¿ safety iv catheter with bd multiguard¿ technology there was leakage at the catheter and hub junction.The following information was provided by the initial reporter.The customer stated: "after catheter placement, the infusion was started and leakage was then observed.When the hcp checked the product, the leakage was occurring around the area between the catheter and the catheter hub.".
 
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Brand Name
BD CATHENA¿ SAFETY IV CATHETER WITH BD MULTIGUARD¿ TECHNOLOGY
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
phillip emmert
9450 south state street
sandy, UT 84070
8015296192
MDR Report Key12976874
MDR Text Key284816917
Report Number8041187-2021-01039
Device Sequence Number1
Product Code FOZ
UDI-Device Identifier00382903868070
UDI-Public00382903868070
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K172506
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 01/10/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/10/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Model Number386807
Device Catalogue Number386807
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/22/2021
Is the Reporter a Health Professional? Yes
Date Manufacturer Received01/10/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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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