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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST PAUL DELTEC SET, ADMINISTRATION, INTRAVASCULAR

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ST PAUL DELTEC SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Model Number 21-2861-24
Device Problem Material Fragmentation (1261)
Patient Problem Device Embedded In Tissue or Plaque (3165)
Event Date 10/01/2020
Event Type  Injury  
Event Description
It was reported that during the administration of seven day continous chemotherapy, the gripper needle broke leaving the needle sticking out of the skin of the patient. An extraction was performed. The extracted product was discarded. No further complications were reported in relation to this event.
 
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Brand NameDELTEC
Type of DeviceSET, ADMINISTRATION, INTRAVASCULAR
Manufacturer (Section D)
ST PAUL
1265 grey fox rd.
st. paul MN 55112
Manufacturer (Section G)
NULL
1265 grey fox rd.
st. paul MN 55112
Manufacturer Contact
david halverson
6000 nathan lane north
minneapolis, MN 55442
MDR Report Key10803489
MDR Text Key215117024
Report Number3012307300-2020-11130
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Reporter Country CodeAE
PMA/PMN Number
K021999
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,foreign,other
Reporter Occupation
Type of Report Initial,Followup
Report Date 11/30/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/06/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number21-2861-24
Device Catalogue Number21-2861-24
Device Lot Number3922529
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received11/02/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 11/06/2020 Patient Sequence Number: 1
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