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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON BD ARTERIAL CANNULA 20G/45MM; INTRAVASCULAR CATHETER
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BECTON DICKINSON BD ARTERIAL CANNULA 20G/45MM; INTRAVASCULAR CATHETER Back to Search Results
Catalog Number 682245
Device Problems Break (1069); Leak/Splash (1354); Material Separation (1562)
Patient Problem Foreign Body In Patient (2687)
Event Date 03/05/2024
Event Type  Injury  
Event Description
It was reported that bd arterial cannula 20g/45mm catheter broke / separated after placement.The following information was provided by the initial reporter: description of incident: on arrival to ccu post operatively patients arterial line started to bleed.Pressure applied and nurse called for help.On removal of the gauze when bleeding stopped it was noted that the arterial line had snapped and retained within the patient¿s artery.The patient had to be returned to theatre to have this removed under local anaesthetic confirmation of a product fault/failing.
 
Manufacturer Narrative
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 numbers 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.We would be very interested in examining product that does not meet your expectations and our quality standards.Should you again experience any problems with our product we would appreciate the opportunity to conduct a thorough analysis of the affected device.Examination of the product involved may provide clarification as to the cause for the reported failure.We regret any inconveniences this incident may have caused you and your facility.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.
 
Event Description
Description of incident: on arrival to ccu post operatively patients arterial line started to bleed.Pressure applied and nurse called for help.On removal of the gauze when bleeding stopped it was noted that the arterial line had snapped and retained within the patient¿s artery.The patient had to be returned to theatre to have this removed under local anaesthetic confirmation of a product fault/failing.
 
Manufacturer Narrative
Based on the dhr review, there is an outgoing inspection to inspect for product damaged during the in-process inspection, no catheter tubing defect qn being raise for the assembly needle (an) batch used to produce this complaint batch.No photo was received.No sample was received.If there was a sample received, the broken catheter can be investigated to determine its cause, the complaint will be re-open when there is a sample received.The complaint trend will be monitored.H3 other text : see h10 manufacture narrative.
 
Manufacturer Narrative
Correction supplemental for change in f code.No sample returned for investigation h3 other text : see h10 manufacture narrative.
 
Event Description
Description of incident: on arrival to ccu post operatively patients arterial line started to bleed.Pressure applied and nurse called for help.On removal of the gauze when bleeding stopped it was noted that the arterial line had snapped and retained within the patient¿s artery.The patient had to be returned to theatre to have this removed under local anaesthetic confirmation of a product fault/failing.
 
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Brand Name
BD ARTERIAL CANNULA 20G/45MM
Type of Device
INTRAVASCULAR CATHETER
Manufacturer (Section D)
BECTON DICKINSON
1 becton drive
franklin lakes NJ 07417
Manufacturer (Section G)
BECTON DICKINSON MEDICAL (SINGAPORE)
30 tuas avenue 2
singapore NJ 07417
Manufacturer Contact
helen cox (mdr)
75 north fairway drive
vernon hills, IL 60061
8473935694
MDR Report Key18991798
MDR Text Key338886337
Report Number2243072-2024-00452
Device Sequence Number1
Product Code FOZ
UDI-Device Identifier00382906822451
UDI-Public(01)00382906822451
Combination Product (y/n)N
Reporter Country CodeUK
PMA/PMN Number
UNK
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup,Followup
Report Date 05/13/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number682245
Device Lot Number2309336
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 03/05/2024
Initial Date FDA Received03/28/2024
Supplement Dates Manufacturer Received04/03/2024
04/03/2024
Supplement Dates FDA Received04/23/2024
05/14/2024
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/08/2022
Is the Device Single Use? Yes
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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