MAUDE Adverse Event Report: CARDINAL HEALTH 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)
Date of Event	10/20/2021
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
The customer reported the catheter disconnected when lightly touched.
Additional Manufacturer Narrative
Please disregard report number 9612030-2021-03068;further communication was received from the customer stating that the catheter was intentionally removed from the patient, no detachment occurred.The device did not malfunction and no adverse events occurred.No further follow up reports will be submitted regarding this event.

• Brand Name: P400 PREM U/M 16FR SL TMP CSD
• Common Device Name: DEVICE, URINE FLOW RATE MEASURING, NON-ELECTRICAL, DISPOSABLE
• Manufacturer (Section D): CARDINAL HEALTH; calle 9 sur no. 125 cuidad ind; tijuana 22500 ; MX 22500
• MDR Report Key: 12698920
• Report Number: 9612030-2021-03068
• Device Sequence Number: 3855908
• 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,user f
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 11/03/2021

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: 2113141764
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 10/20/2021
• Supplement Date Received by Manufacturer: 10/20/2021
• Initial Report FDA Received Date: 10/26/2021
• Supplement Report FDA Received Date: 11/03/2021
• Patient Sequence Number: 1