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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL (SINGAPORE) BD INSYTE ¿ IV CATHETER VIALON-E WINGED INTRAVASCULAR CATHETER

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BECTON DICKINSON MEDICAL (SINGAPORE) BD INSYTE ¿ IV CATHETER VIALON-E WINGED INTRAVASCULAR CATHETER Back to Search Results
Catalog Number 388444
Device Problem Device Packaging Compromised (2916)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 12/07/2017
Event Type  malfunction  
Manufacturer Narrative
Investigation results: 4 photos were returned for investigation. 1 actual sample in opened packaging was returned for investigation. Our quality engineer inspected the returned units and photos, and confirmed the reported complaint but could not identify any manufacturing related defects. A device history record review was conducted and no quality notification was raised for similar nonconformance during the production of the batch. Conclusions: there is an indication of adhesive transferred from the top web to the bottom web on the opened seal areas, which was present on the returned sample showing that the sealing process was completed in manufacturing facility. Therefore, no assignable root cause can be established. Customer complaint trends are evaluated on a monthly basis. If the trend of a specific type of complaint warrants a formal corrective action, resources will be assigned at that time.
 
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 before use, a bd insyte ¿ iv catheter vialon-e winged was found with a breach in package integrity as part of the package was reported open. There was no report of injury or medical intervention reported.
 
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Brand NameBD INSYTE ¿ IV CATHETER VIALON-E WINGED
Type of DeviceINTRAVASCULAR 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
brett wilko
9450 south state street
sandy, UT 84070
8015652845
MDR Report Key7164979
MDR Text Key250442267
Report Number8041187-2017-00281
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
N/A
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,other,user facility
Reporter Occupation
Type of Report Initial,Followup
Report Date 01/24/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/04/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Expiration Date07/31/2019
Device Catalogue Number388444
Device Lot Number4204020
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/19/2017
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/11/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/22/2014
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 01/04/2018 Patient Sequence Number: 1
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