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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 Detachment of Device or Device Component (2907)
Patient Problem Foreign Body In Patient (2687)
Event Date 09/28/2022
Event Type  Injury  
Event Description
It was reported by the customer that the bd¿ arterial cannula detached and remained in the patient.The following information was provided by the initial reporter: during this process the catheter part of the device became detached and remained in the patient.It had to be surgically removed.
 
Manufacturer Narrative
Initial reporter phone #: (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 by the customer that the bd¿ arterial cannula detached and remained in the patient.The following information was provided by the initial reporter: during this process the catheter part of the device became detached and remained in the patient.It had to be surgically removed.
 
Manufacturer Narrative
The following fields were updated due to additional information: d10: device available for eval yes.D10: returned to manufacturer on: 14-dec-2022.One sample was received by our quality team for evaluation.From the sample, a broken catheter was observed.The part-off surfaces on both ends were examined and a clean cut was observed.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.The machine parts that contact the catheter tubing were the machine grippers.However, the machine grippers have a round flat surface with no sharp edges that could cause part-off 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 which 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 carried out by using scissors to part-off a catheter.The part-off surface was then observed.Based on this simulation, the broken catheter could have been caused by a sharp object such as scissors.According to the instructions for use (ifu), scissors are not be used at or near the insertion site.Therefore, the root cause could not be established.H3 other text : see h10.
 
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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
phillip emmert
9450 south state street
sandy, UT 84070
8015296192
MDR Report Key15664331
MDR Text Key302332697
Report Number8041187-2022-00613
Device Sequence Number1
Product Code NDP
Combination Product (y/n)N
Reporter Country CodeAU
PMA/PMN Number
NA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,User Facility,Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 12/08/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/24/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number682245
Device Lot Number2088595
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Date Manufacturer Received12/21/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/29/2022
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) Other;
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