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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL (SINGAPORE) BD VENFLON ¿ PRO SAFETY IV CATHETER
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BECTON DICKINSON MEDICAL (SINGAPORE) BD VENFLON ¿ PRO SAFETY IV CATHETER Back to Search Results
Catalog Number 393228
Device Problems Fail-Safe Design Failure (1222); Retraction Problem (1536)
Patient Problem Needle Stick/Puncture (2462)
Event Date 05/11/2018
Event Type  Injury  
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 after use a bd venflon ¿ pro safety iv catheter safety device failed as" the needle does not retract into the safety mechanism".This malfunction resulted in the anesthesiologist being stuck three times.There was no report of medical intervention given at that time.Upon further follow up it was reported "according to the information i have there was no infection.".
 
Manufacturer Narrative
5 representative samples and 1 photo were returned for investigation.Actual sample was not returned.Representative samples returned (batch#7290053) from the returned photo, it was observed that the cannula was exposed and not contained within the needle cap safety mechanism.The 5 representative samples were subjected to visual inspection and separation force test.All the 5 representative samples passed the acceptance criteria (refer to attachment e) and safety mechanism were activated properly.Safety mechanism activated.The returned photo shows that the cannula was exposed and not contain within the needle cap safety mechanism.Actual sample was not returned.The 5 representative samples passed the acceptance criteria.Investigation conclusion: the returned photo shows that the cannula was exposed and not contained within the needle cap safety mechanism.However the non-conformance of this complaint could not be determined as the representative sample passed the acceptance criteria.
 
Event Description
It was reported that after use a bd venflon pro safety iv catheter safety device failed as" the needle does not retract into the safety mechanism".This malfunction resulted in the anesthesiologist being stuck three times.There was no report of medical intervention given at that time.Upon further follow up it was reported "according to the information i have there was no infection.".
 
Event Description
It was reported that after use a bd venflon ¿ pro safety iv catheter safety device failed as "the needle does not retract into the safety mechanism.This malfunction resulted in the anesthesiologist being stuck three times." there was no report of medical intervention given."confirmation received from the customer - no blood test has been carried out, it can not be determined if an infection has occurred".
 
Manufacturer Narrative
Confirmation received from the customer - no blood test has been carried out, it can not be determined if an infection has occurred.
 
Manufacturer Narrative
Correction: due to an it issue beginning on (b)(6) 2018, previously filed emdrs did not contain required fields.This supplemental emdr is filed to provide the following omitted fields: device single use?: no.Device returned to manufacturer: no.Type of reportable events: serious injury.
 
Event Description
It was reported that after use a bd venflon ¿ pro safety iv catheter safety device failed as" the needle does not retract into the safety mechanism".This malfunction resulted in the anesthesiologist being stuck three times.There was no report of medical intervention given at that time.Upon further follow up it was reported "according to the information i have there was no infection.".
 
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Brand Name
BD VENFLON ¿ PRO SAFETY IV CATHETER
Type of Device
IV CATHETER
Manufacturer (Section D)
BECTON DICKINSON MEDICAL (SINGAPORE)
30 tuas avenue 2
singapore
MDR Report Key7579354
MDR Text Key110459801
Report Number8041187-2018-00204
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 distributor,foreign,other
Type of Report Initial,Followup,Followup,Followup
Report Date 08/17/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/07/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other Health Care Professional
Device Expiration Date10/31/2020
Device Catalogue Number393228
Device Lot Number7290053
Date Manufacturer Received05/14/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
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