MAUDE Adverse Event Report: COVIDIEN SALEM SUMP TUBE 6FR 24IN; TUBES, GASTROINTESTINAL (AND ACCESSORIES)

Model Number	8888268060
Medical Device Problem Code	Suction Failure (4039)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/05/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The complainant indicated that the device will not be returned for evaluation as it has been discarded; 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 or Problem Description
The customer reported that the salem sump was not suctioning well.The nurse irrigated it with sterile water and found a leak near the air port.There was no patient injury.Additional information provided stated that the tubing was not functioning at all.
Additional Manufacturer Narrative
A review of the device history record revealed no discrepancies that may have contributed to the reported condition.A product analysis was unable to be completed as to date no samples or pictures have been provided.The most likely root cause for the reported could be due to a workmanship issue.The operator at the assembly station is responsible for introducing a bonding agent to the pigtail and catheter assembly, however, if this step is missed, leaking could occur.The root cause for the reported condition cannot be specifically identified; therefore, corrective action will be limited to retraining the personal.A production notification was issued to staff members to ensure that they are aware of the condition reported by the customer.If additional information is received warranting further analysis, the investigation may be resumed.This complaint will be used for tracking and trending purposes.

• Brand Name: SALEM SUMP TUBE 6FR 24IN
• Common Device Name: TUBES, GASTROINTESTINAL (AND ACCESSORIES)
• Manufacturer (Section D): COVIDIEN; calle 9 sur no. 125 cuidad ind; tijuana 22500 ; MX 22500
• MDR Report Key: 9865779
• Report Number: 9612030-2020-02437
• Device Sequence Number: 13584833
• Product Code: KNT
• UDI-Device Identifier: 10884521007741
• UDI-Public: 10884521007741
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/03/2020

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: No Information
• Device Model Number: 8888268060
• Device Catalogue Number: 8888268060
• Device Lot Number: 1933709264
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/15/2020
• Supplement Date Received by Manufacturer: 03/15/2020
• Initial Report FDA Received Date: 03/23/2020
• Supplement Report FDA Received Date: 06/03/2020
• Patient Sequence Number: 1