MAUDE Adverse Event Report: COVIDIEN 8888264887 18CH PVC SALEM SUMP 120CMX25; TUBES, GASTROINTESTINAL (AND ACCESSORIES)

Model Number 8888264887

Device Problem Nonstandard Device (1420)

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

Event Date 07/26/2021

Event Type  malfunction  

Manufacturer Narrative

The complainant indicated that the device will not be returned for evaluation; therefore, a failure analysis is not available, and we are not able to determine the relationship between this device and the cause for this event.  as part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product.  if additional information or the sample is received, the investigation will be reopened and responded to accordingly.

Event Description

The customer reported that the ng tube was placed in the patient and after checking the placement several times, they were not able to use the device.After withdrawing the ng tube, it was confirmed that the device did not have any holes.There was no patient injury.

Manufacturer Narrative

Additional information the device history record (dhr) review showed that all acceptance criteria inspections, per established sampling levels, were within acceptable limits during the production process of this lot number.The sample was not available for evaluation as it was discarded by the customer.If a sample should be returned at a later date this complaint will be reopened and the investigation updated to reflect our findings.There was a photo provided which has been reviewed by the team and the site can confirm the reported condition.A review of the complaints and the salem sump line was completed by the quality engineer, process engineer and production supervisor to try and determine the root cause.Following this review, it was determined that the most probable root cause was operator error.The catheter was transferred from the trim, mark and melt station to the coli and pouch station omitting the punch / occlusion station.A corrective and preventative action (capa) has been opened to further investigate this report and to implement effective solutions to prevent re-occurrence of this issue.A quality alert has been issued to the manufacturing line to make them aware of the complaint.The associated data will be fed into the risk management quarterly report.This complaint will be used for tracking and trending purposes.

• Brand Name: 8888264887 18CH PVC SALEM SUMP 120CMX25
• Type of Device: TUBES, GASTROINTESTINAL (AND ACCESSORIES)
• Manufacturer (Section D): COVIDIEN; sragh industrial estate, co, t; offaly ; EI
• MDR Report Key: 12255387
• MDR Text Key: 264396025
• Report Number: 9611018-2021-00526
• Device Sequence Number: 1
• Product Code: KNT
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 10/18/2021

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
• Device Operator: No Information
• Device Model Number: 8888264887
• Device Catalogue Number: 8888264887
• Device Lot Number: 20B070FHX
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/28/2021
• Initial Date FDA Received: 07/30/2021
• Supplement Dates Manufacturer Received: 07/28/2021
• Supplement Dates FDA Received: 10/18/2021
• Patient Sequence Number: 1