MAUDE Adverse Event Report: COVIDIEN CONNECT FEED STE 1000ML NS; PUMP, INFUSION, ENTERAL

Model Number	77100FD
Medical Device Problem Code	Air/Gas in Device (4062)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/27/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The incident sample has been requested but to date has not been received for evaluation.If the sample is received, or if additional information pertinent to the incident is obtained a follow-up report will be submitted.
Event or Problem Description
The customer reported that during the morning assessment the rn noted a significant amount of air in the tubing.The rn reprimed the tubing and reconnected it to the patient.About an hour later it had sucked air in through the line again.They replaced the bag and tubing and examined the old clip and tubing to see if there was a tear or hole and when they did that, the tubing came disconnected completely from the clip mechanism.There was no patient harm.
Additional Manufacturer Narrative
Investigation summary: the customer reported a significant amount of air was seen in the tubing but an rn during a morning assessment.The rn re-primed the tubing and reconnected it to the patient.About an hour later, air was seen in the line again.The bag and tubing were replaced and examination of the old clip and tubing was performed to see if there was a tear or hole.When this examination took place, the tubing disconnected completely from the clip mechanism.There was no patient injury/harm reported.A device history record (dhr) review was unable to be performed as the reported lot number was unknown.One used sample was returned for evaluation.Visual inspection confirmed the pvc tubing was disconnected from the cassette.The root cause of the confirmed product issue is related to the pvc tubing diameter.A corrective action for the extrusion process has been completed and is documented within a formal investigation.This event will be used for tracking and trending purposes.

• Brand Name: CONNECT FEED STE 1000ML NS
• Common Device Name: PUMP, INFUSION, ENTERAL
• Manufacturer (Section D): COVIDIEN; 15 hampshire street; mansfield MA 02048
• MDR Report Key: 11348817
• Report Number: 1282497-2021-09923
• Device Sequence Number: 16990060
• Product Code: LZH
• UDI-Device Identifier: 10884521190825
• UDI-Public: 10884521190825
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 06/23/2021

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
• Operator of Device: No Information
• Device Model Number: 77100FD
• Device Catalogue Number: 77100FD
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 02/16/2021
• Supplement Date Received by Manufacturer: 02/16/2021
• Initial Report FDA Received Date: 02/19/2021
• Supplement Report FDA Received Date: 06/23/2021
• Patient Sequence Number: 1