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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL (SINGAPORE) BD VENFLONTM PRO SAFETY 14 G IV CATHETER INTRAVASCULAR CATHETER

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BECTON DICKINSON MEDICAL (SINGAPORE) BD VENFLONTM PRO SAFETY 14 G IV CATHETER INTRAVASCULAR CATHETER Back to Search Results
Catalog Number 393270
Device Problem Fail-Safe Design Failure (1222)
Patient Problem Needle Stick/Puncture (2462)
Event Date 02/27/2016
Event Type  Injury  
Manufacturer Narrative
(b)(4). (b)(6). Device evaluation: result - a sample is available for evaluation but has not been received. One photo was received which shows the cannula tip exposed on the bottom of the needle cap. A review of the device history record revealed no abnormalities during the manufacture of the reported lot number 5355074. Conclusion - bd was able to confirm the customer's indicated failure mode from evaluation of the returned photo. Without an actual sample, an absolute root cause for this incident cannot be determined. Once a sample is received, an evaluation will be performed and a supplemental submitted.
 
Event Description
It was reported the needle tip was not completely covered by the safety mechanism of the suspect device. The clinician sustained a needle stick injury. No interventions were provided to the clinician or patient. "they just made a compression and a plaster on the wound. ".
 
Manufacturer Narrative
Results: one used sample was returned for evaluation. The square cover of the safety mechanism was removed and a visual examination revealed no damage or abnormalities to the "shark fin" or v-clip. The catheter hub was not returned for evaluation. A manufacturing review revealed no abnormalities with preventative maintenance, calibration, or equipment that could have influenced the customer's reported issue. As previously reported, a review of the device history record revealed no abnormalities during the manufacture of the reported lot number 5355074. Conclusion: an absolute root cause for this incident cannot be determined as bd was not able to duplicate or confirm the customer¿s indicated failure mode. Remedial action required: although a root cause for this incident could not be determined, capa (b)(4) has been initiated to investigate the needle stick injury associated with this device.
 
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Brand NameBD VENFLONTM PRO SAFETY 14 G IV CATHETER
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 Key6405685
MDR Text Key69992663
Report Number8041187-2017-00027
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Reporter Country CodeGM
PMA/PMN Number
NA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,o
Reporter Occupation
Remedial Action Other
Type of Report Initial,Followup
Report Date 04/28/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/15/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date12/31/2018
Device Catalogue Number393270
Device Lot Number5355074
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/27/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/21/2015
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage
Removal/Correction Number82497

Patient Treatment Data
Date Received: 03/15/2017 Patient Sequence Number: 1
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