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

Model Number	P4P16XTS
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.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 that the foley detached from the closed system at the connection point, under the tamper evident seal.There was no patient harm reported.
Additional Manufacturer Narrative
The lot number received was not a valid number since it had one extra digit than the lot numbers that are generated by the manufacturing facility.A possible lot is 2014015664, which was found as the most similar number to the reported by the customer.The device history record (dhr) was reviewed based on most probable lot 2014015664, and no abnormal process conditions were present during the manufacturing of the product that could have led to the condition described by the customer.The dhr review showed that all acceptance criteria inspections per established sampling levels were within acceptable limits during the production process.The sample was not provided for evaluation therefore the reported condition could not be confirmed.The root cause and action plan will be documented through a formal corrective/preventative action which has been initiated to address the reported condition to mitigate any further occurrences.This action is currently ongoing.This complaint will be closed with no further action and will be used for tracking and trending purposes.

• Brand Name: P400 PREM U/M 16FR SL TMP SNS
• 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: 11516504
• Report Number: 9612030-2021-02815
• Device Sequence Number: 4087901
• Product Code: FFG
• UDI-Device Identifier: 10884521069060
• UDI-Public: 10884521069060
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/17/2021

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: P4P16XTS
• Device Catalogue Number: P4P16XTS
• Device Lot Number: 20140115664
• Initial Date Received by Manufacturer: 03/09/2021
• Supplement Date Received by Manufacturer: 03/09/2021
• Initial Report FDA Received Date: 03/18/2021
• Supplement Report FDA Received Date: 05/17/2021
• Patient Sequence Number: 1