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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL (SINGAPORE) BD¿ ARTERIAL CANNULA
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BECTON DICKINSON MEDICAL (SINGAPORE) BD¿ ARTERIAL CANNULA Back to Search Results
Catalog Number 682245
Device Problem Break (1069)
Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/14/2022
Event Type  malfunction  
Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.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 the catheter broke while using the bd¿ arterial cannula.The following information was provided by the initial reporter: "faulty arterial cannula that appears to have broken off inside the patients artery.".
 
Event Description
It was reported that the catheter broke while using the bd¿ arterial cannula.The following information was provided by the initial reporter: "faulty arterial cannula that appears to have broken off inside the patients artery.".
 
Manufacturer Narrative
The following fields have been corrected: imdrf annex e grid: code: 2401 imdrf annex f grid: code: f24 h.6.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.H3 other text : see h.10.
 
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Brand Name
BD¿ ARTERIAL CANNULA
Type of Device
ARTERIAL CANNULA
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 Key15007404
MDR Text Key300804337
Report Number8041187-2022-00367
Device Sequence Number1
Product Code NDP
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 08/24/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/13/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number682245
Device Lot Number1231730
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received08/22/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/19/2021
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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