MAUDE Adverse Event Report: COVIDIEN TUBE SALEM 14FR; TUBES, GASTROINTESTINAL (AND ACCESSORIES)

Model Number	264945
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/16/2021
Type of Reportable Event	Malfunction
Additional 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 or Problem Description
The customer reported the last centimeter of the salem sump tube which is inserted into the stomach was bent over and torn.This was noticed before use.
Additional Manufacturer Narrative
The device history record was reviewed and indicated that the product was released accomplishing all quality standards.The assembly process has been developed in accordance with the approved specifications.One unused sample with lot number 1914101264 was received for evaluation.After performing a visual inspection, a curvature at the tip of the catheter can be observed.The reported issue was confirmed.The most probable root cause was determined to be due to a workmanship issue; when the tube was slid into the bag, it was not confirmed that the tip was straight inside the paper bag.A quality alert was created to notify the production personnel in the suction area of the confirmed bent tip.The standard work instructions were modified to include a catheter tip inspection step.Going forward, this will mitigate the risk of the tip bending.At this time, no further actions are deemed necessary.This complaint will be used for tracking and trending purposes.

• Brand Name: TUBE SALEM 14FR
• 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: 12217280
• Report Number: 9612030-2021-03000
• Device Sequence Number: 19763875
• Product Code: KNT
• UDI-Device Identifier: 10884521067202
• UDI-Public: 10884521067202
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/05/2021

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
• Operator of Device: No Information
• Device Model Number: 264945
• Device Catalogue Number: 264945
• Device Lot Number: 1914101264
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 07/19/2021
• Supplement Date Received by Manufacturer: 07/19/2021
• Initial Report FDA Received Date: 07/23/2021
• Supplement Report FDA Received Date: 10/05/2021
• Patient Sequence Number: 1