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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 388434
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. Opened seal was observed in the returned photos. 3 actual samples in opened packaging were returned for investigation. The actual samples were subjected to visual inspection. Our quality engineer inspected the returned units and confirmed the reported observation but could not identify any manufacturing related defects. Opened seal was observed on all returned samples for batch 3322458, batch 4297106, and batch 5354382. Device history record was reviewed for all three batches and no quality notification was raised for similar nonconformance during the production of any incident batch. Conclusion: there is an indication of adhesive transferred from the top web to the bottom web on the opened seal areas, which was present on all returned samples and thus, showed 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
There were multiple lot numbers reported to be involved. The information for each lot number is as follows: medical device lot #: 3322458, medical device expiration date: 2018-11-30, device manufacture date: 2013-12-21. Medical device lot #: 5354382, medical device expiration date:2020-12-31, device manufacture date: 2016-01-18. Medical device lot #: 4297106, medical device expiration date: 2019-10-31, device manufacture date: 2014-12-06. 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 vialon-e was found with a breach in package integrity. 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 Key7164340
MDR Text Key251788799
Report Number8041187-2017-00280
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 Catalogue Number388434
Device Lot NumberSEE H.10
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
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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