MAUDE Adverse Event Report: VYGONGMBH NUTRILINE; LONG-TERM INTRAVASCULAR CATHETER

Model Number 1252.30

Device Problems Break (1069); Material Rupture (1546); Material Integrity Problem (2978); Migration (4003)

Patient Problem Foreign Body In Patient (2687)

Event Date 09/16/2023

Event Type  malfunction  

Manufacturer Narrative

This complaint could not be classified as no root cause analysis can be made due to missing samples.According to the complaint form, we got the following information: as a continue of the (b)(4), in the same patient, our customer had another problem with the second catheter which 1252.30 had broken after the second day of the implementation.To wrap up, the customer used 1261.20 first, after it was broken, the clinic had to implement 1252.30 which is broken again.Furthermore, we received additional information upon our request: the baby was born in the 35th week and a weight of 1540 g.Although the catheter was used for tpn infusion, the hospital claimed that during this period no disinfectant came in contact with the catheter.A hospira plum 360 iv pump from icu medical was used for tpn infusion at a flow of 10 cc/h.Delayed, we got further information: "after 2 days of catheter insertion, it separated from the endpoint of the luer lock hub.When they noticed the catheter rupture, they saw that the catheter had advanced 1 cm into the vein from the insertion points and they called the pediatric surgeon to remove the catheter.The pediatric surgeon made a 1.5 cm incision and removed the catheter from the patient." no sample was returned by the hospital, but we received an image showing that the catheter tube snapped just distal the wing.There are various events that can lead to a snapped catheter tube at the wing which may be caused by: 1.Dressing change- in some instances, the catheter can become adhered to the dressing and additional pulling is required to free it.Placing stress on the line could result in a tensile fracture.In babies, routine care (when lifting the baby to change the bedding) and movement of the baby itself could result in a tensile fracture.2.Mechanical damage by a sharp instrument (for example scissor, toothed forceps or scalpel) during dressing change.3.Alcohol-based disinfectant.Concerning this, there are some warnings in the ifu: "be aware that organic solvents such as alcohol or acetone may interact with catheter material and weaken it." and "avoid any contact of the catheter tubing to alcohol-containing disinfectants.This may irreversibly damage the catheter." having checked the batch history records, no deviations were found.The batch complied with its specifications and was released.Each catheter is flow and leak-tested during production.The tensile force and dimensions of catheter components are randomly checked.The min.Value of 3.00 n is requested regarding the tensile force at break for the junction of the catheter tube and wing.For the involved code 4g31252400, for batch 8186321 the range was between 3.03 n and 6.84 n and therefore within the specification.Incoming goods inspections and two 100% visual tests after packaging are carried out.There is one further complaint for batch 270922gn and eight further complaints regarding a snapped catheter tube at the wing on code 1252.30 within the last three years.For your information, the general complaint rate for code 1252.30 from 2020 to 2022 was at 0.591 per mille.No further corrective action was initiated by quality management as the catheter is leak and flow tested before packaging and worked well for two days before the defect occurred.

Event Description

After 2 days of catheter insertion, it separated from the wing.When they noticed the catheter rupture, they saw that the catheter had advanced 1 cm into the vein from the insertion points and they called the pediatric surgeon to remove the catheter.The pediatric surgeon made a 1.5 cm incision and removed the catheter from the patient.".

• Brand Name: NUTRILINE
• Type of Device: LONG-TERM INTRAVASCULAR CATHETER
• Manufacturer (Section D): VYGONGMBH; prager ring 100; aachen, 52070 ; GM 52070
• Manufacturer (Section G): VYGONGMBH; prager ring 100; aachen, 52070 ; GM 52070
• Manufacturer Contact: freda lacroix ; 2750 morris road; lansdale, PA 19446 ; 8004735414
• MDR Report Key: 17975101
• MDR Text Key: 327131161
• Report Number: 2245270-2023-00074
• Device Sequence Number: 1
• Product Code: LJS
• Combination Product (y/n): N
• Reporter Country Code: TU
• PMA/PMN Number: K051690
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/19/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/20/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: 1252.30
• Device Lot Number: 270922GN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/19/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention