MAUDE Adverse Event Report: COVIDIEN P400 PREM U/M 16FR TMP SNS CSD; PUMP, INFUSION, ENTERAL

Model Number P4P16TSD

Device Problem Material Separation (1562)

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

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.  if additional information or the sample is received, the investigation will be reopened and responded to accordingly.

Event Description

The customer reported that the green anti-tamper wrap on the foley is not keeping the foley attached securely to the drainage system.The drainage system was found unattached with the green plastic wrap intact.There was no patient injury.

Manufacturer Narrative

A device history record review could not be performed because a lot number was not received with the complaint.As part of our manufacturing process, all device history records are reviewed and approved by quality, prior to the release of product.A sample was not received for the investigation.Because a sample was not returned, we were unable to perform a follow up investigation to include functional and visual evaluations to confirm the reported condition and determine the root cause.If samples are received at a later date, the complaint will be reopened, and the investigation will be updated accordingly.As part of continuous improvement, a corrective and preventative action plan has been opened to address the reported condition through a more robust investigation.The results of the investigation will be documented through the capa.This complaint will be used for tracking and trending purposes.

• Brand Name: P400 PREM U/M 16FR TMP SNS CSD
• Type of Device: PUMP, INFUSION, ENTERAL
• Manufacturer (Section D): COVIDIEN; calle 9 sur no. 125 cuidad ind; tijuana 22500 ; MX 22500
• MDR Report Key: 11095662
• MDR Text Key: 225731100
• Report Number: 9612030-2020-02734
• Device Sequence Number: 1
• Product Code: LZH
• UDI-Device Identifier: 10884521066960
• UDI-Public: 10884521066960
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 02/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/30/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: P4P16TSD
• Device Catalogue Number: P4P16TSD
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/29/2020
• Patient Sequence Number: 1