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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL (SINGAPORE) 20 G X .32 MM BD VENFLON¿ PRO SAFETY PERIPHERAL SAFETY IV CATHETER INTERVASCULAR CATHETER

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BECTON DICKINSON MEDICAL (SINGAPORE) 20 G X .32 MM BD VENFLON¿ PRO SAFETY PERIPHERAL SAFETY IV CATHETER INTERVASCULAR CATHETER Back to Search Results
Catalog Number 393224
Device Problems Break (1069); Fail-Safe Design Failure (1222)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 07/07/2017
Event Type  malfunction  
Manufacturer Narrative
Results: investigation five representative samples were returned for investigation. Four out of five samples are from batch # 6362492. One of the sample is from batch # 6265250. The five representative samples were subjected to visual inspection of the catheter tubing, cannula tip, v-clip, and tether foil. There is no non-conformance found on the catheter tubing and cannula. The five representative samples were manually activated and the cannula was contained in the safety mechanism. V-clips were activated properly. No abnormality was observed on the tether foil. The dhr and manufacturing process have been reviewed and there is no abnormality found for batch # 6362492. The five representative samples passed the acceptance criteria. The non-conformance was not observed on the five representative samples. 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.
 
Manufacturer Narrative
There is no 510(k) for this device as it is manufactured outside the us and not sold in the us. A device evaluation is anticipated, but has not yet begun. Upon completion of the investigation, a supplemental report will be filed. (b)(4).
 
Event Description
It was reported the guide was curved and broken and the needle came out on the 20 g x. 32 mm bd venflon¿ pro safety peripheral safety iv catheter after use. The safety failed to function properly. No medical interventions.
 
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Brand Name20 G X .32 MM BD VENFLON¿ PRO SAFETY PERIPHERAL SAFETY IV CATHETER
Type of DeviceINTERVASCULAR 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 Key6772990
MDR Text Key249725035
Report Number8041187-2017-00065
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Reporter Country CodeIT
PMA/PMN Number
N/A
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 09/15/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/08/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Expiration Date12/31/2019
Device Catalogue Number393224
Device Lot Number6362492
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/11/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/13/2017
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: 08/08/2017 Patient Sequence Number: 1
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