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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: GEM V/NV CKV 3 SS 20DP 20PK INTRAVASCULAR ADMINISTRATION SET

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GEM V/NV CKV 3 SS 20DP 20PK INTRAVASCULAR ADMINISTRATION SET Back to Search Results
Model Number 2426-0500
Device Problems Leak/Splash (1354); Device Contamination with Chemical or Other Material (2944)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 05/27/2021
Event Type  malfunction  
Manufacturer Narrative
The customer's address is unknown. Unknown, (b)(6) usa has been used as a default. Fda notified?: the initial reporter also notified the fda via medwatch #mw5102450 no product or photo was returned by the customer. The complaint could not be verified due to the product not being returned for failure investigation. A device history record review for the model and lot number was performed. There were no quality notifications issued for the failure mode reported by the customer during the production build of this set. Due to no sample being received, an investigation could not be performed and a root cause could not be determined. This incident has been added to our database of reported incidents. Our business team regularly reviews the collected data for identification of emerging trends.
 
Event Description
It was reported gem v/nv ckv 3 ss 20dp 20pk was damaged causing separation between the infusion set and tubing. The following information was provided by the initial reporter: "new bd alaris pump infusion set and the tubing was not connected to the chamber below the spike. This break sterility/cleanliness of the product and it needed to be wasted. ".
 
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Brand NameGEM V/NV CKV 3 SS 20DP 20PK
Type of DeviceINTRAVASCULAR ADMINISTRATION SET
MDR Report Key12383926
MDR Text Key268733809
Report Number9616066-2021-51922
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
PMA/PMN Number
K944320
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other
Type of Report Initial
Report Date 08/03/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/30/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number2426-0500
Device Catalogue Number2426-0500
Device Lot Number20053476
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/02/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/22/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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