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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 Problems Leak/Splash (1354); Device Contamination with Chemical or Other Material (2944)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 08/30/2021
Event Type  Injury  
Manufacturer Narrative
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 bd arterial cannula experienced catheter separation from the hub and leakage.During removal, a portion of the device remained embedded within the patient.The following information was provided by the initial reporter: problem-free insertion with the help of the ultrasound of an arterial cannula for perioperative monitoring, problem-free acceptance of the invasive blood pressure measurement.In the awr planned removal of the cannula for further relocation to the peripheral station.Suddenly a very bloody puncture site.When pulling the cannula suddenly no complete removal is possible.Broken piece remained in the blood vessel.
 
Manufacturer Narrative
The following fields were updated due to additional information: d.9.Device available for eval?: yes.D.9.Returned to manufacturer on: 10/21/2021.H.6.Investigation: four photos and two samples were received by our quality team for evaluation.From the samples, a broken catheter was observed.One kinked area was observed on the catheter tubing.A clean cut was observed on the part-off edges of the catheter tubing.A kinked area was observed on the catheter tubing and no broken catheter was seen on the second sample.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.The arterial cannula tube draw machine was reviewed and the machine parts that contact the catheter tubing are the machine grippers.However, the machine grippers have a round flat surface with no sharp edges that could cause part-off or kink in the catheter tubing.The arterial cannula assembly machine was also reviewed.There is 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 is broken, its lie distance would most likely have failed and will automatically be rejected by the line.A simulation was conducted by using scissors to cut the catheter tubing of an arterial cannula.The part-off end of the catheter tubing was observed under a scope.A clean cut is observed on the part-off area of the catheter tubing which is similar to that of the returned actual sample.Therefore, the broken catheter could have been caused by a sharp object such as a scissors.Based on the investigation, the broken / kinked catheter could have been caused outside the manufacturing process.H3 other text : see h.10.
 
Event Description
It was reported that the bd arterial cannula experienced catheter separation from the hub and leakage.During removal, a portion of the device remained embedded within the patient.The following information was provided by the initial reporter: problem-free insertion with the help of the ultrasound of an arterial cannula for perioperative monitoring, problem-free acceptance of the invasive blood pressure measurement.In the awr planned removal of the cannula for further relocation to the peripheral station.Suddenly a very bloody puncture site.When pulling the cannula suddenly no complete removal is possible.Broken piece remained in the blood vessel.
 
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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
katie swenson
9450 south state street
sandy, UT 84070
8015296192
MDR Report Key12557205
MDR Text Key274112904
Report Number8041187-2021-00877
Device Sequence Number1
Product Code NDP
Combination Product (y/n)N
Reporter Country CodeSZ
PMA/PMN Number
NA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,Distributor
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 11/18/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/30/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number682245
Device Lot Number1112461
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/21/2021
Is the Reporter a Health Professional? Yes
Date Manufacturer Received11/18/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/22/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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