MAUDE Adverse Event Report: COVIDIEN P400 PREM U/M 16FR SL TMP CSD; DEVICE, URINE FLOW RATE MEASURING, NON-ELECTRICAL, DISPOSABLE

Model Number	P4P16XTSD
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
Customer reports: there were ten known incidents of catheters disconnecting during use.The cases are recent and started happening in the last 4-5 weeks.Additional information may not be available because lot information is usually discarded.The devices are mostly used in the or setting.The staff has been instructed to check the devices before use and to contain any that are disconnected.The green tape on the catheter has become very loose whereas it used to be so tight you couldn't twist it and would need scissors to get it un done.Now the green tape is very loose when they open it and she cans spin it around and move it around right away which doesn't seem right.
Additional Manufacturer Narrative
A device history record (dhr) review could not be performed because a lot number was not available.A sample analysis is not applicable because there were no samples or digital image submitted with this complaint.The complaint will be reopened if a sample is received.The reported condition could not be confirmed.Because no samples or photos were received for evaluation, the condition reported could not be confirmed.However, there have been cases reported previously for catheter detachment for which a corrective and preventative action (capa) was opened.This capa will address the reported condition through a more robust investigation.Results of the investigation will be documented through the referred capa.This complaint will be used for tracking and trending purposes.

• Brand Name: P400 PREM U/M 16FR SL TMP CSD
• Common Device Name: DEVICE, URINE FLOW RATE MEASURING, NON-ELECTRICAL, DISPOSABLE
• Manufacturer (Section D): COVIDIEN; calle 9 sur no. 125 cuidad ind; tijuana 22500 ; MX 22500
• MDR Report Key: 11672294
• Report Number: 9612030-2021-02864
• Device Sequence Number: 3104779
• Product Code: FFG
• UDI-Device Identifier: 10884521066984
• UDI-Public: 10884521066984
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,consum
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/14/2021

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: P4P16XTSD
• Device Catalogue Number: P4P16XTSD
• Initial Date Received by Manufacturer: 04/09/2021
• Supplement Date Received by Manufacturer: 04/09/2021
• Initial Report FDA Received Date: 04/15/2021
• Supplement Report FDA Received Date: 06/14/2021
• Patient Sequence Number: 1