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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL (SINGAPORE) BD INSYTE¿ IV CATHETER INTRAVASCULAR CATHETER

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BECTON DICKINSON MEDICAL (SINGAPORE) BD INSYTE¿ IV CATHETER INTRAVASCULAR CATHETER Back to Search Results
Model Number 381244
Device Problem Loose or Intermittent Connection (1371)
Patient Problem Pain (1994)
Event Date 04/14/2022
Event Type  malfunction  
Event Description
It was reported that the needle was loose in the bd insyte¿ iv catheter during use. The following information was provided by the initial reporter, translated from (b)(6): "catheter without the part that fixes the bevel. When catheterizing the peripheral access in the patient, the beveled needle rotates. ".
 
Manufacturer Narrative
Investigation summary: no photos or samples were received by our quality team for evaluation therefore the failure mode could not be verified. 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. Complaints received for this product and condition will continue to be tracked and trended. Information will be captured on trend reports and monitored. Our business regularly reviews the collected data for identification of emerging trends.
 
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Brand NameBD INSYTE¿ IV CATHETER
Type of DeviceINTRAVASCULAR 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 Key14338517
MDR Text Key291234560
Report Number8041187-2022-00242
Device Sequence Number1
Product Code FOZ
UDI-Device Identifier30382903812449
UDI-Public30382903812449
Combination Product (y/n)N
Reporter Country CodePO
PMA/PMN Number
K151698
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
Report Date 04/27/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/09/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number381244
Device Catalogue Number381244
Device Lot Number1321175
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received04/18/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/17/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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