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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: GEM V/NV 20DP CKV 2SS 0.2MF LOW SORBING INTRAVASCULAR ADMINISTRATION SET

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GEM V/NV 20DP CKV 2SS 0.2MF LOW SORBING INTRAVASCULAR ADMINISTRATION SET Back to Search Results
Model Number 11532269
Device Problems Leak/Splash (1354); Device Contamination with Chemical or Other Material (2944)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/27/2021
Event Type  malfunction  
Manufacturer Narrative
Device expiration date: unknown. Device manufacture date: unknown. Investigation summary: one sample was received or quality investigation. The customer complaint of component damage - no leak was not verified by sample investigation. Evaluation of the sample submitted, indicates that the sample tubing separated at the outlet port of the filter and the tubing. Closer inspection of the separation location indicates that the outlet port or the tubing, did not show signs of epoxy at the union site, and therefore easily separated at that location. A device history record review could not be performed on model 11532269 because a lot number was not provided by the customer. The root cause for the issue seen in this complaint is a manufacturing issue. Due to the lack of epoxy applied to the assembly, the infusion set separated at the filter outlet port and tubing. This incident has been added to our database of reported incidents. Our business team regularly reviews the collected data for identification of emerging trends. Investigation conclusion: the root cause for the issue seen in this complaint is a manufacturing issue. Due to the lack of epoxy applied to the assembly, the infusion set separated at the filter outlet port and tubing.
 
Event Description
It was reported that the gem v/nv 20dp ckv 2ss 0. 2mf low sorbing experienced device damage while still considered operable. The following information was provided by the initial reporter: rn was changing over iv fluid/ iv tubing per policy, when she was about to connect the new tpn line, noted something had fallen to floor. It was then she noticed that the iv tubing had broken apart at a filter. The connection that broke was not a connection segment that can normally disconnect.
 
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Brand NameGEM V/NV 20DP CKV 2SS 0.2MF LOW SORBING
Type of DeviceINTRAVASCULAR ADMINISTRATION SET
MDR Report Key12367073
MDR Text Key268120918
Report Number9616066-2021-51890
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,user facility
Type of Report Initial
Report Date 07/30/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/25/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Model Number11532269
Device Catalogue Number11532269
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/05/2021
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/28/2021
Was Device Evaluated by Manufacturer? Yes
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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