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 Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that the tubing disconnected from the catheter itself.There were no balloon issues.The catheter remained in the patient, but the tubing disconnected from the catheter, sliding out without manipulating or tearing of the green tape.There was no patient injury reported.
Additional Manufacturer Narrative
The lot number was provided, and the device history record (dhr) was reviewed indicating that the product was released accomplishing all quality standards.As part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product.The device was manufactured on 08-sep2020.The physical sample is not available for the evaluation.Per customer, the sample was discarded.A representative picture has been provided for the evaluation.Upon visual inspection, the catheter is seen detached from the adapter sampling port.Therefore, the reported condition is confirmed.There have been cases reported in the past for catheter detachment, of which a corrective and preventative action (capa) was opened in october 2020 in order to address the reported condition through a more robust investigation.The results of the investigation will be documented through the capa.Any further actions will be designed to prevent the reoccurrence of the reported condition.

• 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: 12249290
• Report Number: 9612030-2021-03013
• Device Sequence Number: 4370940
• Product Code: FFG
• UDI-Device Identifier: 10884521066984
• UDI-Public: 10884521066984
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/02/2021

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
• Device Lot Number: 2025100664
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/27/2021
• Supplement Date Received by Manufacturer: 07/27/2021
• Initial Report FDA Received Date: 07/29/2021
• Supplement Report FDA Received Date: 08/02/2021
• Patient Sequence Number: 1