Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL (SINGAPORE) BD ARTERIAL CANNULA 20G/1.10MM X 45MM
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

BECTON DICKINSON MEDICAL (SINGAPORE) BD ARTERIAL CANNULA 20G/1.10MM X 45MM Back to Search Results
Catalog Number 682245
Device Problems Leak/Splash (1354); Device Contamination with Chemical or Other Material (2944)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 02/19/2020
Event Type  malfunction  
Manufacturer Narrative
(b)(6).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 an unspecified number of bd arterial cannulas 20g/1.10mm x 45mm experienced a catheter that broke/separated from the hub.Product defect was noted after use.The following information was provided by the initial reporter: when removing the arterial cannula, the cannula sleeve (the part that lies in the artery) came loose.
 
Manufacturer Narrative
H.6.Investigation summary: one sample was received by our quality team for evaluation.Upon visual inspection it was observed that the catheter tubing of the returned sample appeared to be broken.The leftover tubing is estimated to be 2mm long.The broken area was observed further under a microscope and two markings were observed on the nose area of the flow-switch housing.It was a clean cut.The incident could be verified.A simulation was carried out on a different arterial cannula by using scissors to brush past the nose area before cutting off the catheter tubing.This device was observed under the microscope as well.Similar marks and cutting was observed on that one as well.A device history record review found no non-conformances associated with this issue during production of this batch.The manufacturing process was reviewed.There are no metal parts that would contact the nose area of the flow-switch.There is also an automated vision inspection machine at the arterial cannula assembly machine, and it will auto reject any parts not meeting the lie distance requirement.If the catheter tubing was broken during manufacturing, its lie distance would most likely have failed and will automatically be rejected by the line.Based on the investigation, the broken catheter tubing mostly likely occurred by being cut by a sharp object such as a scissors during user application.The root cause of the broken catheter in the returned sample cannot be determined based on the above investigation.The broken catheter could have happened outside manufacturing process.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
It was reported that an unspecified number of bd arterial cannulas 20g/1.10mm x 45mm experienced a catheter that broke/separated from the hub.Product defect was noted after use.The following information was provided by the initial reporter: when removing the arterial cannula, the cannula sleeve (the part that lies in the artery) came loose.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
BD ARTERIAL CANNULA 20G/1.10MM X 45MM
Type of Device
ARTERIAL CANNULA
Manufacturer (Section D)
BECTON DICKINSON MEDICAL (SINGAPORE)
30 tuas avenue 2
singapore
MDR Report Key9872182
MDR Text Key186722398
Report Number8041187-2020-00161
Device Sequence Number1
Product Code NDP
Combination Product (y/n)N
PMA/PMN Number
NA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,other,user facility
Type of Report Initial,Followup
Report Date 04/07/2020
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 Other
Device Catalogue Number682245
Device Lot Number9235959
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 03/03/2020
Initial Date FDA Received03/24/2020
Supplement Dates Manufacturer Received03/03/2020
Supplement Dates FDA Received04/08/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
-
-