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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 386862
Device Problem Material Deformation (2976)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/07/2022
Event Type  malfunction  
Event Description
It was reported that 1 bd cathena¿ safety iv catheter with bd multiguard¿ technology sheared during insertion.The following information was provided by the initial reporter : it was reported that the catheter sheared during insertion.Incident date : (b)(6) 2021.
 
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.Medical device manufacture date : unknown.
 
Manufacturer Narrative
Additional information : the additional information after original report submission required notification in the records.The following fields have been updated: d.4.Medical device expiration date : 30-jun-2024 d.4.Medical device lot # : 1175136 h.4.Device manufacture date : 24-jun-2021 h.6.Investigation summary : 1.Exec summary - one actual used sample was received.The catheter tubing was detached from the adapter and the adapter was connected to the extension set.There was a jagged break-off point on the catheter tubing near the nose of the catheter adapter.The manufacturing process was reviewed and no station was found to be able to cause this kind of jagged cut observed on the catheter tubing.- as the returned sample was used, actual root cause could not be determined.- a review of the complaint lot history check was performed and this is the 1st related complaint for (catheter defective or damaged) on this lot # 1175136.No non-conformances were raised in association with this type of event for this lot concluding all inspections were performed as per the applicable operations and met qc specifications.2.Capa/sa - based on the above no additional investigation and no corrective or preventative action (capa) or situational analysis (sa) are required at this time.3.Dhr review - a lot history review for batch # 1175136 was carried out and no related non conformances were raised in association with this packaged lot concluding all inspections were performed as per the applicable operations and met qc specifications.H3 other text : see h.10.
 
Event Description
It was reported that 1 bd cathena¿ safety iv catheter with bd multiguard¿ technology sheared during insertion.The following information was provided by the initial reporter : it was reported that the catheter sheared during insertion.Incident date : (b)(6) 2021.
 
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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 Key13577919
MDR Text Key286346393
Report Number8041187-2022-00093
Device Sequence Number1
Product Code FOZ
UDI-Device Identifier00382903868629
UDI-Public00382903868629
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K201717
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 03/29/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/22/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Model Number386862
Device Catalogue Number386862
Device Lot Number1175136
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Date Manufacturer Received03/31/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/24/2021
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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