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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL (SINGAPORE) BD VENFLON¿ PRO SAFETY SHIELDED IV CATHETER; INTRAVASCULAR CTHETER
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BECTON DICKINSON MEDICAL (SINGAPORE) BD VENFLON¿ PRO SAFETY SHIELDED IV CATHETER; INTRAVASCULAR CTHETER Back to Search Results
Catalog Number 393230
Device Problem Leak/Splash (1354)
Patient Problem Blood Loss (2597)
Event Date 12/09/2019
Event Type  malfunction  
Manufacturer Narrative
"there were multiple "possible" lot numbers reported to be involved.The information for each lot number is as follows: medical device lot #: 9060946.Medical device expiration date: 2022-02-28.Device manufacture date: 2019-03-15.Medical device lot #: 9241669.Medical device expiration date: 2022-08-31.Device manufacture date: 2019-08-29.Medical device lot #: 9270361.Medical device expiration date: 2022-09-30.Device manufacture date: 2019-09-27." initial reporter phone #: unknown.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 during induction of anesthesia a "popping" sound occurred and blood leaked through the port with a bd venflon¿ pro safety shielded iv catheter.The following information was provided by the initial reporter: during induction of anesthesia via the drug port of a freshly inserted 14g bd venflon pro safety, a 'popping' sensation was felt followed by the immediate free flow of blood back through the drug port on the removal of the syringe.The blood flow did not stop with closure of the orange cap and only stopped with manual occlusion of the drug port with gauze and pressure.The patient lost a small volume of blood (<50mls) and some of the induction drugs may have been lost along with the blood.The cannula had to be removed so the patient had a second cannulation that would have been unnecessary otherwise.
 
Event Description
It was reported that during induction of anesthesia a "popping" sound occurred and blood leaked through the port with a bd venflon¿ pro safety shielded iv catheter.The following information was provided by the initial reporter: during induction of anesthesia via the drug port of a freshly inserted 14g bd venflon pro safety, a 'popping' sensation was felt followed by the immediate free flow of blood back through the drug port on the removal of the syringe.The blood flow did not stop with closure of the orange cap and only stopped with manual occlusion of the drug port with gauze and pressure.The patient lost a small volume of blood (<50mls) and some of the induction drugs may have been lost along with the blood.The cannula had to be removed so the patient had a second cannulation that would have been unnecessary otherwise.
 
Manufacturer Narrative
H.6.Investigation: three photos and eight representative samples were received by our quality team for evaluation.The returned photos show the top web with batch number.The eight representative samples were subjected to visual inspection, valve injection test, and catheter adapter leak test.The eight representative samples passed the visual inspection and acceptance criteria on valve injection test and catheter adapter leak test.No abnormality was observed; therefore, the incident could not be verified.A device history record review found no non-conformances associated with this issue during production of this batch.Since all of the samples passed testing a probable root cause could not be determined.
 
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Brand Name
BD VENFLON¿ PRO SAFETY SHIELDED IV CATHETER
Type of Device
INTRAVASCULAR CTHETER
Manufacturer (Section D)
BECTON DICKINSON MEDICAL (SINGAPORE)
30 tuas avenue 2
singapore
MDR Report Key9667288
MDR Text Key183142900
Report Number8041187-2020-00041
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 03/19/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/04/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number393230
Device Lot NumberSEE H.10
Date Manufacturer Received01/15/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
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