Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST PAUL DELTEC; SET, ADMINISTRATION, INTRAVASCULAR
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

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.
 
Manufacturer Narrative
B5: updated with additional information.
 
Event Description
Additional information was received indicating that a deltec gripper plus needle from the same lot number (3922529) as the as the discarded product (post removal) would be sent for device evaluation.Additionally, a photograph of the discarded product was examined.The examination revealed that the needle was twisted.The complaint was therefore confirmed by the photographic examination.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
DELTEC
Type of Device
SET, ADMINISTRATION, INTRAVASCULAR
Manufacturer (Section D)
ST PAUL
1265 grey fox rd.
st. paul MN 55112
MDR Report Key10803489
MDR Text Key215117024
Report Number3012307300-2020-11130
Device Sequence Number1
Product Code FPA
UDI-Device Identifier10610586025655
UDI-Public10610586025655
Combination Product (y/n)N
PMA/PMN Number
K021999
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,foreign,other
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 No Information
Device Model Number21-2861-24
Device Catalogue Number21-2861-24
Device Lot Number3922529
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Date Manufacturer Received11/02/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
-
-