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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: NEOMED, INC. NEOCONNECT ENTERAL FEEDING TUBE; TUBE, NASOGASTRIC
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NEOMED, INC. NEOCONNECT ENTERAL FEEDING TUBE; TUBE, NASOGASTRIC Back to Search Results
Model Number PFTL5.0P-NC
Device Problems Migration or Expulsion of Device (1395); Detachment of Device or Device Component (2907)
Patient Problem Pressure Sores (2326)
Event Date 02/16/2020
Event Type  malfunction  
Event Description
Ng tube for infant with screw in end-piece.With this device the cap is secured to the feeding tube by its loop but can freely migrate up and down length of tube when opened for period of time in which feeding is administered by feeding pump.Infant was noted to have moved his head during feeding and screw cap migrated down length of tube and put pressure on infant's face.Small indentation noted on face at end of feeding when syringe was detached and rn sought screw cap end to close off end of feeding tube.Concern over pressure ulcer potential or choking hazard due to freely movable piece.
 
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Brand Name
NEOCONNECT ENTERAL FEEDING TUBE
Type of Device
TUBE, NASOGASTRIC
Manufacturer (Section D)
NEOMED, INC.
100 londonberry ct, suite 112
woodstock GA 30188
MDR Report Key9928225
MDR Text Key186539998
Report Number9928225
Device Sequence Number1
Product Code FPD
UDI-Device Identifier00817584011748
UDI-Public(01)00817584011748
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Nurse
Type of Report Initial
Report Date 03/09/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/06/2020
Is this a Product Problem Report? Yes
Device Operator No Information
Device Model NumberPFTL5.0P-NC
Device Catalogue NumberPFTL5.0P-NC
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA03/09/2020
Event Location Hospital
Date Report to Manufacturer04/06/2020
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age30 DA
Patient Weight2
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