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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL (SINGAPORE) ANGIOCATH PLUS 18GA X 1.16IN CATHETER

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BECTON DICKINSON MEDICAL (SINGAPORE) ANGIOCATH PLUS 18GA X 1.16IN CATHETER Back to Search Results
Catalog Number 382444
Device Problems Break (1069); Leak/Splash (1354); Device Contamination with Chemical or Other Material (2944)
Patient Problem Thrombus (2101)
Event Date 09/10/2020
Event Type  Injury  
Manufacturer Narrative
Date of event: unknown. The date received by manufacturer has been used for this field. Medical device expiration date: unknown, the initial reporter also notified the fda on 26 march, 2020. Medwatch report # (b)(4). Report source other: medwatch report. A device evaluation and/or device history review is anticipated, but is not complete. Upon completion, a supplemental report will be filed. Device manufacture date: unknown. (b)(4).
 
Event Description
It was reported that angiocath plus 18ga x 1. 16in catheter was damaged. This was discovered after use. The following information was provided by the initial reporter: material no: 382444 batch no: unknown. It was reported that upon removal of the catheter, a small piece was noticed to be missing. An ultrasound was performed and no echogenic material was seen but a nonocclusive mural thrombus was seen. Event description per email states: patient care technician was removing this patient¿s iv as he was being discharged. Upon removal, they observed that the tip of the iv was missing a small piece. The physician was called and ordered a ultrasound of the patient¿s are to be done. There was no echogenic material seen in the vein but there was a nonocclusive mural thrombus. This iv was placed on (date redacted). We do not know the lot number as the packaging was not saved, but the dressing which we believe is the original dressing, has the numbers 3348493 on the tape.
 
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Brand NameANGIOCATH PLUS 18GA X 1.16IN
Type of DeviceCATHETER
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 Key10564184
MDR Text Key207922200
Report Number8041187-2020-00595
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
NA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other,user facility
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup,Followup
Report Date 10/16/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/21/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number382444
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/10/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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: 09/21/2020 Patient Sequence Number: 1
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