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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: GEM 20DP CKV 3SS DEHP FREE INTRAVASCULAR ADMINISTRATION SET

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GEM 20DP CKV 3SS DEHP FREE INTRAVASCULAR ADMINISTRATION SET Back to Search Results
Model Number 2426-0007
Device Problem Device Contamination with Chemical or Other Material (2944)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/21/2021
Event Type  malfunction  
Manufacturer Narrative
Medical device expiration date: unknown. The customer's address is unknown. Unknown, (b)(6) has been used as a default. Device manufacture date: unknown. Investigation summary: a complaint of hair found in the set prior to use was received from the customer. No product or photo was returned by the customer. The customer complaint of foreign matter could not be verified due to the product not being returned for failure investigation. A device history record review could not be performed on model 2426-0007 because a lot number was not provided by the customer. 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 two gem 20dp ckv 3ss dehp free contained foreign matter. The following information was provided by the initial reporter: "set infusion 126in w/ck valve 2426-0007 n/a hair 2. ".
 
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Brand NameGEM 20DP CKV 3SS DEHP FREE
Type of DeviceINTRAVASCULAR ADMINISTRATION SET
MDR Report Key12346328
MDR Text Key267438168
Report Number9616066-2021-51846
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 distributor,other
Type of Report Initial
Report Date 07/26/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/19/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Model Number2426-0007
Device Catalogue Number2426-0007
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/22/2021
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 Initial

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