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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL (SINGAPORE) BD VENFLON¿ PRO SAFETY PERIPHERAL SAFETY IV CATHETER; INTRAVASCULAR CATHETER
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BECTON DICKINSON MEDICAL (SINGAPORE) BD VENFLON¿ PRO SAFETY PERIPHERAL SAFETY IV CATHETER; INTRAVASCULAR CATHETER Back to Search Results
Catalog Number 393224
Device Problem Leak/Splash (1354)
Patient Problems Fatigue (1849); Low Blood Pressure/ Hypotension (1914); Blood Loss (2597)
Event Date 05/06/2019
Event Type  malfunction  
Manufacturer Narrative
Medical device expiration date: unknown.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.
 
Event Description
It was reported that the bd venflon¿ pro safety peripheral safety iv catheter separated from the mating component during use on a patient.The patient was found with the cannula still in their arm and the left side of their body "covered in blood and clots", with a mixture of fluid and blood on the floor surrounding the bed.The patient was "very drowsy" and "hypotensive", with blood pressure at "50/20" as a result of the catheter separation and leakage."2 units of o neg and 2 units of ffp" were required and transfused to the patient, who was also put on a "high dependency unit" of care.The following information was provided by the initial reporter: "the patient was found with bung disconnected from the cannula in his arm and the left side of his body was covered in blood and clots, a mixture of fluid and blood was on the floor surrounding the bedside." "the patient was very drowsy, noted to be hypotensive.Bp was 50/20, patient required transfusion of 2 units of o neg and 2 units of ffp and care on high dependency unit.".
 
Event Description
It was reported that the bd venflon¿ pro safety peripheral safety iv catheter separated from the mating component during use on a patient.The patient was found with the cannula still in their arm and the left side of their body "covered in blood and clots", with a mixture of fluid and blood on the floor surrounding the bed.The patient was "very drowsy" and "hypotensive", with blood pressure at "50/20" as a result of the catheter separation and leakage."2 units of o neg and 2 units of ffp" were required and transfused to the patient, who was also put on a "high dependency unit" of care.The following information was provided by the initial reporter: "the patient was found with bung disconnected from the cannula in his arm and the left side of his body was covered in blood and clots, a mixture of fluid and blood was on the floor surrounding the bedside." "the patient was very drowsy, noted to be hypotensive.Bp was 50/20, patient required transfusion of 2 units of o neg and 2 units of ffp and care on high dependency unit.".
 
Manufacturer Narrative
H.6.Investigation: no photos or samples were received by our quality team for evaluation therefore the failure mode could not be verified and the root cause could not be determined.A device history record could not be evaluated as the lot number is unknown.H3 other text : see h.10.
 
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Brand Name
BD VENFLON¿ PRO SAFETY PERIPHERAL SAFETY IV CATHETER
Type of Device
INTRAVASCULAR CATHETER
Manufacturer (Section D)
BECTON DICKINSON MEDICAL (SINGAPORE)
30 tuas avenue 2
singapore
MDR Report Key9284687
MDR Text Key184848179
Report Number8041187-2019-00897
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 11/11/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number393224
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 10/22/2019
Initial Date FDA Received11/06/2019
Supplement Dates Manufacturer Received10/22/2019
Supplement Dates FDA Received11/12/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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