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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COVIDIEN MP SAFETY SCREW SPIKE SET; ENTERAL FEEDING SPIKE SET

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COVIDIEN MP SAFETY SCREW SPIKE SET; ENTERAL FEEDING SPIKE SET Back to Search Results
Model Number 775659
Device Problems Air Leak (1008); Break (1069); Loose or Intermittent Connection (1371)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 11/18/2016
Event Type  malfunction  
Manufacturer Narrative
Submit date: 12/19/2016.An investigation is currently underway.Upon completion, the results will be forwarded.
 
Event Description
It was reported to covidien on (b)(6) 2016 that a customer had an issue with an enteral feeding spike set.The customer states that there was a lack of connection between the set and the connection of the diet.The set was breaking easily and the diet was leaking from the side.Air bubbles entered into the set.There was no injury reported.
 
Manufacturer Narrative
The device history record was reviewed and indicated that the product was released accomplishing all quality standards.Two used samples were received for evaluation.The sample was visually evaluated.Both samples were found to be clogged with dry formula along the pvc lines that obstructed the tube path at the valve level, no functional evaluation could be performed since the product could not be unclogged.A fault wasn¿t found to be related to manufacturing; possible root cause could be incorrect formula inside the tube or incorrect homogenization process for the formula but since the sample was received on inadequate conditions root cause could not be verified.No corrective actions will apply since failure mode was not confirmed related to manufacturing, it will be confirmed as unknown source.This complaint will be used for tracking and trending purposes.If information is provided in the future, a supplemental report will be issued.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
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Brand Name
MP SAFETY SCREW SPIKE SET
Type of Device
ENTERAL FEEDING SPIKE SET
Manufacturer (Section D)
COVIDIEN
37 blvd. insurgentes libriamento
a la p, la mesa
tijuana
MX 
Manufacturer (Section G)
COVIDIEN
37 blvd. insurgentes libriamento
a la p, la mesa
tijuana
MX  
Manufacturer Contact
edward almeida
15 hampshire street
mansfield, MA 02048
5084524151
MDR Report Key6185286
MDR Text Key63101736
Report Number1282497-2016-01054
Device Sequence Number1
Product Code LZH
Combination Product (y/n)N
Reporter Country CodeBR
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Other
Type of Report Initial,Followup,Followup
Report Date 10/04/2018
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 Number775659
Device Catalogue Number775659
Device Lot Number160150042X
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 12/01/2016
Initial Date FDA Received12/19/2016
Supplement Dates Manufacturer Received12/01/2016
08/08/2018
Supplement Dates FDA Received07/22/2018
10/04/2018
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? Yes
Type of Device Usage Unknown
Patient Sequence Number1
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