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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL (SINGAPORE) SEE H.10 INTERVASCULAR CATHETER

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BECTON DICKINSON MEDICAL (SINGAPORE) SEE H.10 INTERVASCULAR CATHETER Back to Search Results
Catalog Number 383712
Device Problem Break (1069)
Patient Problems Device Embedded In Tissue or Plaque (3165); No Code Available (3191)
Event Date 09/12/2019
Event Type  Injury  
Manufacturer Narrative
Medical device brand name: bd pegasus safety closed iv catheter system (y luer with prn and end cap) 24ga x 0. 75in 0. 7mm x 19mm. 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 the bd pegasus safety closed iv catheter system (y luer with prn and end cap) 24ga x 0. 75in 0. 7mm x 19mm experienced needle broke/detached during use, and a serious injury in the form of a medical intervention. The needle broke off within the patient and surgery was required for its removal. When the nurse gave the patient an injection, the patient moved a bit. During needle retraction, it was found that the needle core was broken from the root of the side hole, and the broken part was left in the patient's blood vessel. Broken needle has been removed by surgery.
 
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Brand NameSEE H.10
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
8015652341
MDR Report Key9130251
MDR Text Key163734567
Report Number8041187-2019-00765
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
PENDING
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,other,user facility
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 11/06/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/27/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Expiration Date03/31/2022
Device Catalogue Number383712
Device Lot Number9081793
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/12/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/22/2019
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: 09/27/2019 Patient Sequence Number: 1
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