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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. BD INSYTE-N¿ AUTOGUARD¿ SHIELDED IV CATHETER; INTRAVASCULAR CATHETER
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BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. BD INSYTE-N¿ AUTOGUARD¿ SHIELDED IV CATHETER; INTRAVASCULAR CATHETER Back to Search Results
Catalog Number 381411
Device Problems Break (1069); Difficult to Remove (1528); Detachment of Device or Device Component (2907)
Patient Problems Swelling (2091); Foreign Body In Patient (2687)
Event Date 04/16/2019
Event Type  malfunction  
Manufacturer Narrative
Date of event: unknown.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 half of the bd insyte-n¿ autoguard¿ shielded iv catheter needle broke off and remained in the patient's skin after the injection, where it could not be seen, and the patient's hand "became swollen" as a result.Attempts were made to receive more information, but no additional information could be provided by the customer.The following information was provided by the initial reporter: "it was reported that the patient's hand became swollen.After injection, the nurse was unable to pull back blood or flush piv.It was also reported that half of the catheter remained in skin and the end point could not be visualized.".
 
Manufacturer Narrative
Investigation: there was no sample or photo available to bd for evaluation.Therefore, bd was unable to perform a thorough investigation to verify the reported issue.Since, an investigation could not be performed bd was unable to determine a possible root cause.A review of the device history record was performed and no quality issues were found during production.
 
Event Description
It was reported that half of the bd insyte-n¿ autoguard¿ shielded iv catheter needle broke off and remained in the patient's skin after the injection, where it could not be seen, and the patient's hand "became swollen" as a result.Attempts were made to receive more information, but no additional information could be provided by the customer.The following information was provided by the initial reporter: "it was reported that the patient's hand became swollen.After injection, the nurse was unable to pull back blood or flush piv.It was also reported that half of the catheter remained in skin and the end point could not be visualized.".
 
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Brand Name
BD INSYTE-N¿ AUTOGUARD¿ SHIELDED IV CATHETER
Type of Device
INTRAVASCULAR CATHETER
Manufacturer (Section D)
BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
9450 south state street
sandy UT 84070
MDR Report Key8569645
MDR Text Key144454761
Report Number1710034-2019-00483
Device Sequence Number1
Product Code FOZ
UDI-Device Identifier30382903814115
UDI-Public30382903814115
Combination Product (y/n)N
PMA/PMN Number
K952861
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other,user facility
Type of Report Initial,Followup
Report Date 05/30/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/01/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date12/31/2020
Device Catalogue Number381411
Device Lot Number8002767
Date Manufacturer Received04/16/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age8 DA
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