MAUDE Adverse Event Report: COVIDIEN DOBBHOFF 12FR;43IN W/STYLET EN; TUBES, GASTROINTESTINAL (AND ACCESSORIES)

Model Number 8884711253E

Device Problems Crack (1135); Fluid/Blood Leak (1250)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

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 they are having a problem with the dobhoff cementing together and cracking when they try to disconnect.Additional information received stated the formula/residue thickens, like a caulking type substance, at which point it is often described by the clinical staff as cementing.The end of the feeding tube merges with the tubing and cannot be removed.The purple, flexible piece, usually in the middle of the two ports, is cracking when they are trying to disconnect the tube.Sometimes the alternative port can still be used, other times, it is leaking and cannot be used.

Manufacturer Narrative

The device history record (dhr) was reviewed and showed no abnormal process conditions present during manufacturing that could have led to the reported condition.The dhr review showed that all acceptance criteria inspections per established sampling levels were within acceptable limits during the production process.The product samples provided by the customer and involved in the mdr were evaluated to determine the cause or contributing factors to the reported unable to remove/leakage issue.One sample was received with the feeding tube attached to the kangaroo¿ nasogastric feeding tube with enfit connection and the other sample had no feeding tube attached to it.A visual inspection was conducted on both samples and the examination revealed that both samples had a residual white colored substance that was rigid and ¿cemented¿ in the polyurethane tube and y-port assembly.Sample units were then cleaned to remove the cemented white substance and functionally leak tested in accordance with cah acceptance sampling inspection procedure applied for the release of y-port and polyurethane assemblies during manufacturing.The inspection and functional leak test revealed a water leak on the ¿feeding port¿ arm of one of the samples.Water appeared to be leaking through a crack observed and present on its arm surface.These types of leaks are not considered common and are not typically seen in manufacturing.No leaks were seen during the inspection of the manufactured lot before its release.Cracks present in the y-port connector area typically indicate that the device was exposed to mechanical stresses potentially caused by over torquing when tightening the feeding tube to the y-port and/or pushing and pulling to try to separate them when stuck together.The second sample received revealed no cracks and/or physical damage, but it was observed that it was returned with feeding formula cemented in the feeding tube.After removing the cementation, the sample was tested, and no leaks were observed.Product performed as intended.The reported event specified that the customer was having a problem with the product ¿cementing together and was cracking¿ when they tried to disconnect the feeding tube from the y-port assembly.¿cementing¿ is caused by formula residue buildup when nutrition is administered.If not properly flushed, formula/residue thickens into a caulking-type substance commonly referred to by clinicians as ¿cementing¿.When cementing occurs, the end of the feeding tube ¿cements¿ to the y-port assembly making it difficult to remove.Proper frequent flushing is necessary in order to prevent the formula from thickening and ¿cementing¿.In this regard, the product labeling specifies the following: dual port feeding tube generic ifu # dc00043391 precautions, step 2 feeding tubes should be flushed frequently to prevent clogging.Suggested flushing schedule: before and after each feeding.Before and after administering medication.Once every four hours during continuous feeding or between intermittent feedings.Each time the feeding set is disconnected.Each time the feeding container is filled/changed.Each time the pump is stopped.Based on all available information, no corrective action plan is required at this time since the reported conditions were not found to have originated from the manufacturing process.We will continue to monitor the process for any adverse trends that require immediate attention.

• Brand Name: DOBBHOFF 12FR;43IN W/STYLET EN
• Type of Device: TUBES, GASTROINTESTINAL (AND ACCESSORIES)
• Manufacturer (Section D): COVIDIEN; calle 9 sur no. 125 cuidad ind; tijuana 22500 ; MX 22500
• MDR Report Key: 11886054
• MDR Text Key: 252712064
• Report Number: 9612030-2021-02921
• Device Sequence Number: 1
• Product Code: KNT
• UDI-Device Identifier: 10884521582927
• UDI-Public: 10884521582927
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,other
• Type of Report: Initial,Followup
• Report Date: 09/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/26/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 8884711253E
• Device Catalogue Number: 8884711253E
• Device Lot Number: 2020501364
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 05/17/2021
• Patient Sequence Number: 1