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U.S. Department of Health and Human Services

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

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ST PAUL DELTEC GRIPPER PLUS NEEDLES; SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Model Number 21-2961-24
Device Problem Obstruction of Flow (2423)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/01/2021
Event Type  malfunction  
Event Description
It was reported, that the customer infused medical fluid (physiological saline solution) into the patient through the product using a syringe.But backflow of medical fluid was not observed.So the customer removed the product from the patient, and passed medical fluid through the product with the syringe connected.However, at that time, medical fluid was unable to be drawn (only air bubble were drawn).No patient injury was reported.
 
Manufacturer Narrative
This remediation mdr was generated under protocol b10010116, as a result of warning letter cms# 6(b)(6).No problems or issues were identified during this device history record review.One sample was received, decontaminated.The sample was received in used condition with its original package.During the functional testing, no occlusion was detected.The complaint was not confirmed.Root cause: based on the analysis conducted in the sample provided, the complaint was not confirmed.
 
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Brand Name
DELTEC GRIPPER PLUS NEEDLES
Type of Device
SET, ADMINISTRATION, INTRAVASCULAR
Manufacturer (Section D)
ST PAUL
1265 grey fox rd.
st. paul MN 55112
Manufacturer (Section G)
NULL
Manufacturer Contact
jim vegel
MDR Report Key16916265
MDR Text Key315082595
Report Number3012307300-2023-05609
Device Sequence Number1
Product Code FPA
UDI-Device Identifier10610586027697
UDI-Public10610586027697
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K021999
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Company Representative
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 05/11/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number21-2961-24
Device Catalogue Number21-2961-24
Device Lot Number4142822
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/29/2021
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 04/24/2023
Initial Date FDA Received05/11/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/03/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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