MAUDE Adverse Event Report: MAQUET CRITICAL CARE AB EDI CATHETER ENFIT 6FR/49 CM, 5PCS; GASTROINTESTINAL TUBES WITH ENTERAL SPECIFIC CONNECTORS

Model Number	6883898
Medical Device Problem Code	Stretched (1601)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/08/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that after removal of the edi catheter, the user measured the length and found that the total length was 52 cm instead of specified 49 cm.There was no patient harm.Manufacturer¿s ref #: (b)(4).
Event or Problem Description
Manufacturer's ref #: (b)(4).
Additional Manufacturer Narrative
An edi catheter, specified for a maximum usage period of five days, was utilized for 24 days.Upon removal, the measured total length was 52 cm, deviating from the specified length of 49 cm.The edi catheter was removed due to clogging after feeding and subsequently returned for investigation.Despite the noted deformation, it was determined that the nava treatment was not affected.The edi signal, being dynamic and responsive to physiological and environmental factors, remained functional during the edi catheter¿s use.Physical measurements found the edi catheter length measured at 520 mm, exceeding the specification of 490 ± 5 mm.The position of the hub was at 440 mm, exceeding the specification of 420 ± 5 mm.The positions of the first and ninth electrode rings were within specification, but the reference electrode position was out of specification.Visual observations noted a discoloration at the tip of the edi catheter, which could indicate chemical degradation, likely caused by prolonged exposure to stomach acid.The electrode rings were intact and not broken.According to manufacturing records, all material parameters were within specified limits.The edi catheter met all final release criteria and there were no identified non-conformities within the batch.In conclusion, the investigation concluded that the edi catheter met all manufacturing specifications and release criteria.The prolongation of the edi catheter noted upon extraction is most likely the result of the extended usage beyond the recommended duration of five days, leading to prolonged exposure to chemical and biological elements in the stomach environment.A correction of field # d1 ¿ brand name, # d4 ¿ version or model #, # d4 - unique identifier (udi) # and # h4 - manufacture date were required.D1 ¿ brand name ¿ previous brand name: enfit edi catheter.Corrected brand name: edi catheter enfit 6fr/49 cm, 5pcs d4 ¿ version or model # - previous version or model #: enfit 6fr/49 cm.Corrected version or model #: 6883898 d4 - unique identifier (udi) # - previous unique identifier (udi) #: missing.Corrected unique identifier (udi) #: (b)(6).H4 - manufacture date ¿ previous manufacture date: missing.Corrected manufacture date: 05/13/2023.

• Brand Name: EDI CATHETER ENFIT 6FR/49 CM, 5PCS
• Common Device Name: 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: caroline kabbabe ; roentgenvagen 2; solna
• MDR Report Key: 18137897
• Report Number: 8010042-2023-02218
• Device Sequence Number: 18154064
• Product Code: PIF
• UDI-Device Identifier: 17325710004606
• UDI-Public: (01)17325710004606
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/15/2023

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: Health Professional
• Device Model Number: 6883898
• Device Catalogue Number: 6883898
• Device Lot Number: 3000314480
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/20/2023
• Supplement Date Received by Manufacturer: 12/12/2024
• Initial Report FDA Received Date: 11/15/2023
• Supplement Report FDA Received Date: 12/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/13/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown