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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 Problem No Code Available (3191)
Event Date 03/25/2020
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 flow switch stopped working during use.As a result, the patient was "awake and moving", and had to have their blood pressure measurement done manually.The following information was provided by the initial reporter: "arterial cannula stops working right after 24h of use.Same incident during last 2 weeks on different patients.We had at least 6 episodes when the cannula is stop working.Which will normally never happens." "in every case, the pressure curve became worse (smaller and smaller).We have run tests on the pressure sets and we cannot find any problems.We experience it as a stop in the artery needle.I talked to icu/postop and they have had similar problems at postop but they sat the problem in connection with patient being awake and moving.With us they are almost always awake and that has not been a problem before." ¿the arteria cannula stopped working quite immediately but in some cases we interpreted it as low pressure before we discovered the erroneous results and did the blood pressure measurement manually.¿ ¿one patient obtained picco-measurement due to failure several times of same arteria cannula.¿.
 
Event Description
It was reported that the bd¿ arterial cannula flow switch stopped working during use.As a result, the patient was "awake and moving", and had to have their blood pressure measurement done manually.The following information was provided by the initial reporter: "arterial cannula stops working right after 24h of use.Same incident during last 2 weeks on different patients.We had at least 6 episodes when the cannula is stop working.Which will normally never happens." "in every case, the pressure curve became worse (smaller and smaller).We have run tests on the pressure sets and we cannot find any problems.We experience it as a stop in the artery needle.I talked to icu/postop and they have had similar problems at postop but they sat the problem in connection with patient being awake and moving.With us they are almost always awake and that has not been a problem before." ¿the arteria cannula stopped working quite immediately but in some cases we interpreted it as low pressure before we discovered the erroneous results and did the blood pressure measurement manually.¿ ¿one patient obtained picco-measurement due to failure several times of same arteria cannula.¿.
 
Manufacturer Narrative
The following fields were updated due to additional information: d.10.Device available for eval?: yes.D.10.Returned to manufacturer on: 4/29/2020.H.6.Investigation: thirteen representative samples were received by our quality team for evaluation.All of the samples were visually inspected for damage on the silicon tubing, burrs/flashes on the catheter tip, damage on the catheter tip, kink in the tubing, and for foreign matter.No abnormality was observed.After the first visual inspection, the needle grip assembly of the samples was removed and another visual inspection of the same parameters was done.No abnormality was observed again.Two of the samples were then sent for x-ray analysis to check if there was any blockage in the silicone tubing area and no blockage was observed.Floswitch button operations force inspection was carried out on the 5 of the catheter samples.All results were within specification.Flowrate testing was conducted on 10 of the samples including the 5 samples which underwent the floswitch button operations force.All results were within specification.The incident 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 investigation, no root cause could be determined since the incident was not verified.If an actual sample involved in the incident is returned for the complaint, the complaint will be re-opened for further investigation.
 
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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 Key9983245
MDR Text Key188809550
Report Number8041187-2020-00219
Device Sequence Number1
Product Code NCP
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 06/26/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/21/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Expiration Date02/29/2024
Device Catalogue Number682245
Device Lot Number9057650
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/29/2020
Date Manufacturer Received04/01/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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