MAUDE Adverse Event Report: COVIDIEN EXT SET BIFURCATED 60 ENFIT; GASTROINTESTINAL TUBES WITH ENTERAL SPECIFIC CONNECTORS

Model Number 60ENY

Device Problem Obstruction of Flow (2423)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/28/2021

Event Type  malfunction  

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.  as part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product.

Event Description

The customer reported that they are having airlock trouble with these extension tubing sets.They have pulled the entire lot and they seem to be fine now.Additional information provided stated that there was either air or a leak in the tubing that did not allow the tubing to prime and have feed flow correctly at a normal rate.The tubing did not leak any feed out of it.There were no patient injuries reported.

Manufacturer Narrative

The device history record (dhr) was reviewed, and no abnormal process conditions were present during the manufacturing of the product that could have led to the condition reported.The dhr review showed that all acceptance criteria inspections per established sampling levels were within acceptable limits during the production process.Fifty-one samples were returned for evaluation consisting of 50 unused samples and 1 used, decontaminated sample.Visual and functional inspections were performed on all 51 samples of which one sample was confirmed to have an occlusion failure (the used sample).The 50 unused samples passed the functional test with acceptable results.Per the procedure, a 100% functional inspection for this failure is done during manufacturing.The most probable root cause is that the production operator did not perform the occlusion test.The failure reported was evaluated against the acceptable quality limit (aql).No action plan is necessary at this time as the complaint reported represents a failure rate much below the approved aql and no trend exists currently.A notification was provided to all production personnel to make them aware of this reported incident.We will keep monitoring the process for any adverse trends that require immediate attention.

• Brand Name: EXT SET BIFURCATED 60 ENFIT
• Type of Device: GASTROINTESTINAL TUBES WITH ENTERAL SPECIFIC CONNECTORS
• Manufacturer (Section D): COVIDIEN; calle 9 sur no. 125 cuidad ind; tijuana 22500 ; MX 22500
• MDR Report Key: 12165696
• MDR Text Key: 261456751
• Report Number: 9612030-2021-02981
• Device Sequence Number: 1
• Product Code: PIF
• UDI-Device Identifier: 10884521212091
• UDI-Public: 10884521212091
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 10/28/2021

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
• Device Operator: No Information
• Device Model Number: 60ENY
• Device Catalogue Number: 60ENY
• Device Lot Number: 1932211264
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 06/28/2021
• Initial Date FDA Received: 07/14/2021
• Supplement Dates Manufacturer Received: 06/28/2021
• Supplement Dates FDA Received: 10/28/2021
• Patient Sequence Number: 1