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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 Scar Tissue (2060)
Event Date 08/03/2019
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 breakage/separation occurred during use with a bd arterial cannula.The following information was provided by the initial reporter, 'on (b)(6) 2019, during using on the patient, the customer withdrew the ac, the customer found that the catheter was broken in the patient.According to the customer's judgment, the broken catheter was left in the body of the patient after penetrate on (b)(6) 2019.The hospital urgently performed the surgical treatment, and finally the surgery took out the broken catheter.Although the broken catheter was removed, the patient's arm was left a long scar by the operation.".
 
Manufacturer Narrative
Investigation: 2 photos were received for the investigation of this complaint.1 actual sample was received for this complaint.The customer¿s experience of catheter broke is confirmed based on the photo and sample evaluation.Both the part-off ends of the catheter tubing were observed under a scope.No elongation or stretch phenomenon can be observed on the catheter tubing to indicate any issue with the tubing material which could have caused the breakage.The surface of the part-off areas appears smooth indicating a clean cut.A simulation was carried out using a scissors to cut the catheter tubing of an arterial cannula sample.After the simulation, both the ends of the catheter tubing were observed under the scope.A clean cut is observed on the part-off areas of the catheter tubing which is similar to that of the returned actual sample.The broken catheter could have been caused by a sharp object such as a scissors.There is no quality notification raised for broken catheter defect for this complaint batch.Arterial cannula tube draw machine the machine parts that contact the catheter tubing were the machine grippers.However, the machine grippers have round flat surface with no sharp edges that could cause the tubing to be broken.The location of the broken catheter shown in figure 1 does not coincide with the location where the machine grippers contact with the catheter tubing.Arterial cannula assembly machine no machine parts were in contact with the tubing broken location of the tubing.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.A broken catheter will automatically be rejected as the lie distance will be out of specification.According to the verbatim, the catheter was placed on the patient on (b)(6) 2019 and withdrawn from patient one day later on (b)(6) 2019.If breakage is present on the catheter tubing, a leakage would likely occur during usage, no leakage of the catheter was reported in the verbatim.Based on the investigation in section 6, the broken catheter could have been caused by a sharp object such as a scissors.According to the instructions for use (ifu) for arterial cannula, scissors are not to be used at or near the insertion site therefore, the root cause of the customer¿s experience on broken catheter could not be established based on the above investigation.
 
Event Description
It was reported that breakage/separation occurred during use with a bd arterial cannula.The following information was provided by the initial reporter, 'on (b)(6) 2019, during using on the patient, the customer withdrew the ac, the customer found that the catheter was broken in the patient.According to the customer's judgment, the broken catheter was left in the body of the patient after penetrate on (b)(6) 2019.The hospital urgently performed the surgical treatment, and finally the surgery took out the broken catheter.Although the broken catheter was removed, the patient's arm was left a long scar by the operation.".
 
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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
MDR Report Key8923318
MDR Text Key155329573
Report Number8041187-2019-00670
Device Sequence Number1
Product Code DWF
Combination Product (y/n)N
PMA/PMN Number
N/A
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 09/10/2019
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 Expiration Date01/31/2024
Device Catalogue Number682245
Device Lot Number9024772
Initial Date Manufacturer Received 08/03/2019
Initial Date FDA Received08/22/2019
Supplement Dates Manufacturer Received08/03/2019
Supplement Dates FDA Received09/10/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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