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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL (SINGAPORE) BD INSYTE¿ IV CATHETER

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BECTON DICKINSON MEDICAL (SINGAPORE) BD INSYTE¿ IV CATHETER Back to Search Results
Catalog Number 381234
Device Problem Retraction Problem (1536)
Patient Problems Hematoma (1884); Discomfort (2330)
Event Date 01/25/2018
Event Type  malfunction  
Manufacturer Narrative
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 during use, a bd insyte¿ iv catheter malfunctioned as ¿the catheter retracts along the needle when being inserted into the vein. This is the second time that this incident occurred, hematoma and discomfort for the patient as a 2nd point of puncture was necessary. Additional invasive procedure resulting in delay in patient management. There was no report of medical intervention.
 
Manufacturer Narrative
Investigation summary: the nonconformance cannot be confirmed as no sample was returned for investigation. The complaint will be reopened if the sample is returned for investigation. A review of the device history record revealed no irregularities during the manufacture of the reported lot number. Investigation conclusion: the root cause cannot be determined as no samples were returned for investigation.
 
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Brand NameBD INSYTE¿ IV CATHETER
Type of DeviceIV CATHETER
Manufacturer (Section D)
BECTON DICKINSON MEDICAL (SINGAPORE)
30 tuas avenue 2
singapore
MDR Report Key7310099
MDR Text Key101626693
Report Number8041187-2018-00039
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
PMA/PMN Number
K151698
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,o
Type of Report Initial,Followup
Report Date 03/14/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/02/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number381234
Device Lot Number7139066
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/05/2018
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 03/02/2018 Patient Sequence Number: 1
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