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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL (SINGAPORE) BD PEGASUS¿ SAFETY CLOSED IV CATHETER SYSTEM INTRAVASCULAR CATHETER

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BECTON DICKINSON MEDICAL (SINGAPORE) BD PEGASUS¿ SAFETY CLOSED IV CATHETER SYSTEM INTRAVASCULAR CATHETER Back to Search Results
Catalog Number 383711
Device Problems Fluid Leak (1250); Hole In Material (1293)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 11/20/2017
Event Type  malfunction  
Manufacturer Narrative
Results: bd received one sample for investigation. Samples were decontaminated. A review of the device history record revealed no irregularities during the manufacture of the reported lot # 7017002. The returned material showed the reported defect. Upon visual examination, the extend tubing was found broken in the middle. The deformation looks to be caused by the slide clamp. The od and id thickness was measured and was found in uniformity of the extend tubing. Microscopic examination revealed no abnormality when measuring the part line flash dimension of the slide clamp. The defect may have been caused by the slide clamp design, the angle of the slide clamp or the material of the extend tubing. However, no abnormalities were found in any of the parameters of the returned sample. Therefore, a root cause cannot be finalized.
 
Event Description
It was reported that when a nurse performed a venipuncture on a patient using a bd pegasus¿ safety closed iv catheter system, the nurse found blood spilled as she opened the clip. As she pulled the device out, she found a hole on the tubing near the hub. There was no report of injury or medical intervention.
 
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Brand NameBD PEGASUS¿ SAFETY CLOSED IV CATHETER SYSTEM
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 Key7154701
MDR Text Key96227574
Report Number8041187-2017-00274
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
N/A
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,o
Reporter Occupation
Type of Report Initial
Report Date 12/12/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/29/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date01/31/2020
Device Catalogue Number383711
Device Lot Number7017002
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/12/2017
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/06/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/27/2017
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: 12/29/2017 Patient Sequence Number: 1
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