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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL (SINGAPORE) BD INSYTE¿ VIALON E IV CATHETER; INTRAVASCULAR CATHETER
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BECTON DICKINSON MEDICAL (SINGAPORE) BD INSYTE¿ VIALON E IV CATHETER; INTRAVASCULAR CATHETER Back to Search Results
Catalog Number 388412
Device Problems Leak/Splash (1354); Device Contamination with Chemical or Other Material (2944)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/25/2021
Event Type  malfunction  
Event Description
It was reported when using the bd insyte¿ vialon e iv catheter the catheter was damaged.The following information was provided by the initial reporter.According to the customer's report (animal clinic), "the catheter was found to be damaged before use.".
 
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 when using the bd insyte¿ vialon e iv catheter the catheter was damaged.The following information was provided by the initial reporter.According to the customer's report (animal clinic), "the catheter was found to be damaged before use.".
 
Manufacturer Narrative
H.6.Investigation: seven photos and one sample were received by our quality team for evaluation.The photo was subjected to visual inspection to check for catheter damage.No obvious catheter damage was observed.The sample was subjected to visual inspection to check for catheter damage.A ¿v-cut¿ was observed near the catheter tip.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 ¿v-cut¿ observed on the catheter that matches the shape of the bevel, could be caused by the needle piercing through the catheter.The assembly process was reviewed.If the needle pierced through catheter occurred in the manufacturing process, the defect would be detected and auto rejected by the 100% inline tip spear vision inspection system.Needle pierced through catheter during the needle cover removal.As the sample was returned in open packaging, the actual root cause could not be established.
 
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Brand Name
BD INSYTE¿ VIALON E IV CATHETER
Type of Device
INTRAVASCULAR CATHETER
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 Key12853377
MDR Text Key281104978
Report Number8041187-2021-00992
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
NA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 12/21/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/22/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number388412
Device Lot Number0357603
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/11/2021
Is the Reporter a Health Professional? Yes
Date Manufacturer Received12/21/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/22/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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