MAUDE Adverse Event Report: COVIDIEN 8888264846 14CH PVC SALEM SUMP 120CMX25; TUBES, GASTROINTESTINAL (AND ACCESSORIES)

Model Number 8888264846

Device Problem Nonstandard Device (1420)

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

Event Date 08/10/2021

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 they wanted to place the salem sump probe but they noticed the device did not have any holes in it.The probe was not placed and a different one was used.This caused a longer wait for the patient.

Manufacturer Narrative

One (1) unused and unopened sample was returned to the manufacturing site in relation to this complaint.The sample returned was visually inspected with no issues found, all eyes are present in the returned catheter.There were photos provided previously and the reported issue was confirmed.The return of the sample has no effect on the complaint investigation completed as the complaint was confirmed from the photo and a corrective and preventative action (capa) has been opened.Please see follow up #1 for the investigation results following the evaluation of the provided photos.

Manufacturer Narrative

The device history record review showed that all acceptance criteria inspections per established sampling levels were within acceptable limits during the production process 20f165fhx.A sample is expected to be received for evaluation however the device is currently experiencing a clearance delay.Once the sample is received at the manufacturing site, the investigation will be reopened and updated to reflect the findings.In the meantime, there was one photo provided for evaluation.The photo was reviewed by the team and the site can confirm the reported issue.A review of the complaint 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 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.

• Brand Name: 8888264846 14CH PVC SALEM SUMP 120CMX25
• Type of Device: TUBES, GASTROINTESTINAL (AND ACCESSORIES)
• Manufacturer (Section D): COVIDIEN; sragh industrial estate, co, t; offaly ; EI
• Manufacturer (Section G): COVIDIEN; sragh industrial estate, co, t; offaly ; EI
• Manufacturer Contact: jill saraiva ; 777 west street; mansfield, MA 02048 ; 5086183640
• MDR Report Key: 12379030
• MDR Text Key: 268521087
• Report Number: 9611018-2021-00531
• Device Sequence Number: 1
• Product Code: KNT
• Combination Product (y/n): N
• Reporter Country Code: NL
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup,Followup
• Report Date: 12/08/2021

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 Model Number: 8888264846
• Device Catalogue Number: 8888264846
• Device Lot Number: 20F165FHX
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/11/2021
• Initial Date FDA Received: 08/27/2021
• Supplement Dates Manufacturer Received: 08/11/2021; 08/11/2021
• Supplement Dates FDA Received: 10/18/2021; 12/08/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: A
• Patient Sequence Number: 1