MAUDE Adverse Event Report: COVIDIEN 777405 EPUMP ENPLUS SPIKE AND 1LT FLUSH; PUMP, INFUSION, ENTERAL

Model Number 777405

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Pain (1994); Vomiting (2144)

Event Type  Injury  

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 the coloring of the feeding set is leaking into the patient's medication.Additional information received on 8-mar-2021 stated that no medication was involved in the incident, the feed was pumped through the set directly into the patient.The patient was doubled up in pain, vomiting and hospitalized ¿ the purple dye was observed on the inside of the feeding tube.The patient was taken to the hospital but the hospital was unable to explain why the patient was so ill.The patient¿s mother has no idea where the purple dye came from, just that it was seen on the inside of the feeding tube and all of the time the patient was on this batch, she was poorly.They switched to a new batch of all feeding equipment and the patient has no further issues.The patient was using two other pieces of equipment which have purple plastic on them.The client is investigating with each individual manufacturer.

Manufacturer Narrative

Additional information received from the original reporting facility stated that after further review they determined the coloring entering the patient¿s feeding equipment was related to the enteral uk syringe.The syringe is not manufactured by cardinal health.However, a thorough investigation of the reported enteral feeding set was conducted.The findings are as follows: the reported lot number was invalid.Based on available information the lot number is most likely 19i149fhx.The device history record for 19i149fhx was reviewed and indicated that the product was released accomplishing all quality standards.Two unused and unopened representative samples were received for evaluation.Neither sample was from the reported lot number.Sample 1 was from lot 19b271fhx and sample 2 was from lot 19j187fhx.The device history record reviews for 19b271fhx and 19j187fhx showed that all acceptance criteria inspections per established sampling levels were within acceptable limits during the production process.Both returned samples were visually inspected with no failures found; there was no abnormal coloring of the sets.Both samples were flow rate tested per procedure and passed with no abnormal coloring observed.In addition, both samples underwent a leak test and an occlusion test.Both samples passed this testing and had no abnormal coloring.Based on the analysis of the returned samples and all available information, the reported issue was unable to be confirmed or duplicated.A corrective action is not applicable at this time.This complaint will be used for tracking and trending purposes.D4 lot number was corrected.

• Brand Name: 777405 EPUMP ENPLUS SPIKE AND 1LT FLUSH
• Type of Device: PUMP, INFUSION, ENTERAL
• Manufacturer (Section D): COVIDIEN; sragh industrial estate, co, t; offaly ; EI
• MDR Report Key: 11509077
• MDR Text Key: 240584169
• Report Number: 9611018-2021-00489
• 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
• Type of Report: Initial,Followup
• Report Date: 06/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/17/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: 777405
• Device Catalogue Number: 777405
• Device Lot Number: 19I149FHX
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 03/08/2021
• Patient Sequence Number: 1
• Patient Outcome(s): Other