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U.S. Department of Health and Human Services

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

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ST PAUL DELTEC GRIPPER MICRO NEEDLES SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Model Number 21-3251-24
Device Problems Connection Problem (2900); Fail-Safe Problem (2936)
Patient Problem No Patient Involvement (2645)
Event Date 09/01/2020
Event Type  malfunction  
Event Description
It was reported that the deltec gripper micro needles gripper failed to latch back into the safety latch. The operator pulled up the safety arm and heard a click sound. The needle was left exposed. This product problem was observed prior to patient use. The product was not used on the patient.
 
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Brand NameDELTEC GRIPPER MICRO NEEDLES
Type of DeviceSET, ADMINISTRATION, INTRAVASCULAR
Manufacturer (Section D)
ST PAUL
1265 grey fox rd.
st. paul MN 55112
Manufacturer (Section G)
ST PAUL
1265 grey fox rd.
st. paul MN 55112
Manufacturer Contact
david halverson
6000 nathan lane north
3-10-15, hakata station east,
minneapolis, MN 55442
MDR Report Key10811622
MDR Text Key215362965
Report Number3012307300-2020-11269
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K072059
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial
Report Date 11/09/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/09/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number21-3251-24
Device Catalogue Number21-3251-24
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received10/12/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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