MAUDE Adverse Event Report: MAQUET CRITICAL CARE AB EDI CATHETER ENFIT; GASTROINTESTINAL TUBES WITH ENTERAL SPECIFIC CONNECTORS

Model Number EDI CATHETER ENFIT 6FR/49CM

Device Problems Fluid/Blood Leak (1250); Obstruction of Flow (2423)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/29/2019

Event Type  malfunction  

Manufacturer Narrative

The investigation has been completed and consists of evaluation of the received information that includes pictures and answers from the hospital to our information requests.It has not been possible to return the edi catheter for investigation due to prevailing health and safety conditions.The edi catheter was in use for 6 days and its nava (neurally adjusted ventilatory assist) functioning was without any problem.According to the hospital, the edi catheter was noted to be leaking and it was therefore replaced.Its examination after removal showed that it had a 2mm longitudinal split at 13.5 cm and beyond this it had a dried white substance.During flushing in the lab examination while manually holding the split closed it was found that the edi catheter had occluded at the distal end.The hospital stated that no leak into patient or chocking was noted before the removal of the edi catheter.The hospital routines of flushing the edi catheters is not after feeding but to flush every after administration of medicine.The hospital was unsure if the routine was followed.The cause of the split and when it occurred has not been determined.The occlusion was most probably caused by non-flushing of the edi catheter after administration.The edi catheter was in the patient for 6 days but the recommended maximum duration of use is 5 days.

Event Description

It was reported that a catheter was placed as an og-tube in the patient and was being used for nava and feeding.The patient was receiving calcium supplementation via the catheter.A leak was discovered and the catheter was removed and replaced with another one.The hospital examined the catheter and discovered that 2 mm longitudinal split at 13.5 cm beyond which the catheter was completely occluded with a dried white substance thought to be a dried calcium supplement.The hospital stated that they had previously attempted to flush the occluded catheter with excessive pressure.There was no patient harm.Manufacturer ref.#: (b)(4).

• Brand Name: EDI CATHETER ENFIT
• Type of Device: GASTROINTESTINAL TUBES WITH ENTERAL SPECIFIC CONNECTORS
• Manufacturer (Section D): MAQUET CRITICAL CARE AB; roentgenvagen 2; solna
• Manufacturer (Section G): MAQUET CRITICAL CARE AB; roentgenvagen 2; solna
• Manufacturer Contact: roentgenvagen 2; solna
• MDR Report Key: 9842303
• MDR Text Key: 189646319
• Report Number: 8010042-2020-00156
• Device Sequence Number: 1
• Product Code: PIF
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K153688
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/17/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: EDI CATHETER ENFIT 6FR/49CM
• Device Catalogue Number: 68 83 898
• Device Lot Number: 92257276
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/21/2020
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/26/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1