MAUDE Adverse Event Report: CARDINAL HEALTH 777506 JOEY ENPLUS 3IN1& 1L FLUSH X36; PUMP, INFUSION, ENTERAL

Model Number 777506

Device Problem Fluid/Blood Leak (1250)

Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/14/2021

Event Type  malfunction  

Manufacturer Narrative

The complainant indicated that the device will not be returned for evaluation; therefore, a failure analysis is not available, and we are not able to determine the relationship between this device and the cause for this event.  as part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product.  if additional information or the sample is received, the investigation will be reopened and responded to accordingly.

Event Description

Customer reports: the sets are separating in the pumping mechanism and spraying feed.

Manufacturer Narrative

Additional information: g2 report source: checked health professional.H6 evaluation codes: health effect - clinical code; medical device problem code; component code; type of investigation; investigation findings; investigation conclusions.Investigation summary: the device history record (dhr) review showed that all acceptance criteria inspections per established sampling levels were within acceptable limits during the production process of lot 21c236fhx.The complaint notification indicated that no samples are available in connection with this complaint as sample were discarded.Without a sample we are unable to perform a thorough follow up investigation to include functional and visual evaluations to determine the root cause(s) of the reported condition or implement any corrective action(s).Unfortunately, without a sample we are unable to confirm the reported condition.If a sample should be returned at a later date, this complaint will be reopened, and the investigation will be updated to reflect our findings.There was one photo provided for evaluation.The photo was reviewed by the team and the manufacturing site can confirm the reported issue from the photo.An exact root cause could not be determined.However, based on the available information a probable root cause could be that there was backup pressure exerted on the peristaltic pump section causing the silicone section to disconnect.The set has a safety feature designed to prevent excess pressure being exerted onto the patient.On this occasion, the safety feature may have been activated and the pressure was diverted away from the patient back up to the peristaltic pump section.At this time, there is not enough information, and a corrective and preventative action will not be initiated.This complaint will be used for tracking and trending purposes.G1 mdr reporting contact name and address: corrected reporting contact address line 1 
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• Brand Name: 777506 JOEY ENPLUS 3IN1& 1L FLUSH X36
• Type of Device: PUMP, INFUSION, ENTERAL
• Manufacturer (Section D): CARDINAL HEALTH; sragh industrial estate, co, t; offaly ; EI
• MDR Report Key: 12207456
• MDR Text Key: 264948611
• Report Number: 9611018-2021-00522
• Device Sequence Number: 1
• Product Code: LZH
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 09/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/21/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 777506
• Device Catalogue Number: 777506
• Device Lot Number: 21C236FHX
• Date Manufacturer Received: 07/20/2021
• Patient Sequence Number: 1