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

Model Number	P4P16SD
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/08/2021
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
Customer reports: the foley catheter disconnected from the drainage bag where the catheter is connected to the bag and 'taped".
Additional Manufacturer Narrative
Additional information: d9, h3, h4, h6.Investigation summary: the device history record (dhr) was reviewed, and no abnormal process conditions were present during the manufacturing of the product that could have led to the condition reported.The dhr review showed that all acceptance criteria inspections per established sampling levels were within acceptable limits during the production process.One decontaminated drainage bag with date code 307-0d62 was received as a representative sample.A visual inspection per our procedure was performed on the received sample and the reported issue was confirmed.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.

• Brand Name: P400 PREM U/M 16FR CATH SECURE
• 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: 11166291
• Report Number: 9612030-2021-02749
• Device Sequence Number: 3719586
• Product Code: FFG
• UDI-Device Identifier: 20884521029597
• UDI-Public: 20884521029597
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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): 03/11/2021

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: P4P16SD
• Device Catalogue Number: P4P16SD
• Device Lot Number: 2019600164
• Initial Date Received by Manufacturer: 01/11/2021
• Supplement Date Received by Manufacturer: 01/11/2021
• Initial Report FDA Received Date: 01/13/2021
• Supplement Report FDA Received Date: 03/11/2021
• Patient Sequence Number: 1