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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL (SINGAPORE) BD VENFLON PRO¿ (BD¿ VIALON BIOMATERIAL) INTRAVASCULAR CATHETER

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BECTON DICKINSON MEDICAL (SINGAPORE) BD VENFLON PRO¿ (BD¿ VIALON BIOMATERIAL) INTRAVASCULAR CATHETER Back to Search Results
Catalog Number 393204
Device Problems Fluid Leak (1250); Hole In Material (1293)
Patient Problem Hematoma (1884)
Event Date 05/15/2018
Event Type  malfunction  
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 with the use of the bd venflon pro¿ (bd¿ vialon biomaterial) there was an issue with leakage. It was stated ¿the patient had a hematoma. When the device was removed the consumer saw that the needle was through the catheter. There was also leakage of infusion liquid from the hole. Device had to be replaced. ¿ there was no report of injury or further medical intervention.
 
Event Description
It was reported with the use of the bd venflon pro¿ (bd¿ vialon biomaterial) there was an issue with leakage. It was stated ¿the patient had a hematoma. When the device was removed the consumer saw that the needle was through the catheter. There was also leakage of infusion liquid from the hole. Device had to be replaced. ¿ there was no report of injury or further medical intervention.
 
Manufacturer Narrative
Investigation summary: the returned unit was inspected and the reported observation of needle through catheter which caused the reported leakage was confirmed. However, the source of the defect could not be determined. A device history record review showed no non-conformance's associated with this issue during the production of this batch. This reported nonconformance could have occurred out of the manufacturing facilities. There is an automated vision inspection system that rejects parts with this type of defect. Investigation conclusion: the returned sample is different from the catalog reported for this complaint. The root cause will be based on the sample received. There is an automated vision inspection system that rejects part not meeting lie distance requirement. A needle pierce though catheter defect will automatically be rejected as the lie distance will be out of specification. There is no process in the manufacturing facilities that could have caused this nonconformance. Therefore, this reported nonconformance could have occurred out of the manufacturing facilities.
 
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Brand NameBD VENFLON PRO¿ (BD¿ VIALON BIOMATERIAL)
Type of DeviceINTRAVASCULAR CATHETER
Manufacturer (Section D)
BECTON DICKINSON MEDICAL (SINGAPORE)
30 tuas avenue 2
singapore
MDR Report Key7570985
MDR Text Key110287991
Report Number8041187-2018-00199
Device Sequence Number1
Product Code FOZ
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 09/04/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/05/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Expiration Date09/30/2020
Device Catalogue Number393204
Device Lot Number7278487
Was Device Available for Evaluation? No Answer Provided
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/24/2018
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 06/05/2018 Patient Sequence Number: 1
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