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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL (SINGAPORE) BD ANGIOCATH¿ PLUS IV CATHETER INTRAVASCULAR CATHETER

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BECTON DICKINSON MEDICAL (SINGAPORE) BD ANGIOCATH¿ PLUS IV CATHETER INTRAVASCULAR CATHETER Back to Search Results
Catalog Number 382412
Device Problem Device Operates Differently Than Expected (2913)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 01/26/2018
Event Type  malfunction  
Manufacturer Narrative
(b)(6). 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 before use of the bd angiocath¿ plus iv catheter there was an issue with silicone. The customer stated ¿that there was uneven silicone on the surface on catheter. ¿ there was no report of injury or further medical intervention.
 
Manufacturer Narrative
Investigation summary: one photo was returned for investigation. We are unable to determine any abnormalities observed in the returned photo as the photo was not clear. Our quality engineer inspected the photo but could not confirm the reported observation. Since no samples displaying the condition reported are available for examination, we were unable to fully investigate this incident. A device history record review was carried out. No notifications were raised for similar nonconformance during the production of this batch. The root cause cannot be determined as no sample was returned for investigation. The complaint will be reopened if the sample is returned for investigation. The nonconformance cannot be confirmed as no sample was returned for investigation.
 
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Brand NameBD ANGIOCATH¿ PLUS IV CATHETER
Type of DeviceINTRAVASCULAR CATHETER
Manufacturer (Section D)
BECTON DICKINSON MEDICAL (SINGAPORE)
30 tuas avenue 2
singapore
MDR Report Key7433724
MDR Text Key105767130
Report Number8041187-2018-00115
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
PMA/PMN Number
K950301
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 05/02/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/16/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number382412
Device Lot Number7265163
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/29/2018
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 04/16/2018 Patient Sequence Number: 1
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