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

Model Number	P4P16TSD
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
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.
Event or Problem Description
The customer reported that while the student nurses were repositioning the patient, the silicone foley catheter detached just above the tamper evident seal.The issue was reported to the assigned rn, who passed the message to the provider.
Additional Manufacturer Narrative
Additional information: h6 investigation summary: 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.Samples were 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 improvements, a corrective and preventative action plan (capa) 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
• 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: 11233460
• Report Number: 9612030-2021-02786
• Device Sequence Number: 19784553
• Product Code: FFG
• UDI-Device Identifier: 10884521066960
• UDI-Public: 10884521066960
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/26/2021

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: P4P16TSD
• Device Catalogue Number: P4P16TSD
• Initial Date Received by Manufacturer: 01/05/2021
• Supplement Date Received by Manufacturer: 01/05/2021
• Initial Report FDA Received Date: 01/26/2021
• Supplement Report FDA Received Date: 02/26/2021
• Patient Sequence Number: 1