MAUDE Adverse Event Report: COVIDIEN CURITY MONO-FLO 16 FR W O PVPI; COLLECTOR, URINE, (AND ACCESSORIES) FOR INDWELLING CATHETER

Model Number	6155MF
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	05/19/2021
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 that the foley catheter was not attached, possibly due to the connecting part coming off.No patient injury was reported.
Additional Manufacturer Narrative
One unused sample was received for evaluation.A visual inspection of the sample was performed according to the procedure and the reported issue is confirmed, the package does not contain the catheter, tamper or sampling port adapter.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 issue 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.Based on the available information the most probable root cause of the problem was originated by improper operator handling; a missing component is a condition generated when an operator fails to complete an assembly or following the predetermined process steps to assure a complete assembly.As part of continuous improvements a procedure modification was made and implemented, in which the operator will inspect 112 packages per hour and record.In addition, a quality alert was generated for this condition and the personnel involved were notified.The current process is running according to product specifications meeting quality acceptance criteria.We will keep monitoring the process for any adverse trends that require immediate attention.

• Brand Name: CURITY MONO-FLO 16 FR W O PVPI
• Common Device Name: COLLECTOR, URINE, (AND ACCESSORIES) FOR INDWELLING CATHETER
• Manufacturer (Section D): COVIDIEN; calle 9 sur no. 125 cuidad ind; tijuana 22500 ; MX 22500
• MDR Report Key: 11872136
• Report Number: 9612030-2021-02917
• Device Sequence Number: 3789508
• Product Code: KNX
• UDI-Device Identifier: 10884521050549
• UDI-Public: 10884521050549
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 07/21/2021

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: 6155MF
• Device Catalogue Number: 6155MF
• Device Lot Number: 2021726864
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 05/20/2021
• Supplement Date Received by Manufacturer: 05/20/2021
• Initial Report FDA Received Date: 05/24/2021
• Supplement Report FDA Received Date: 07/21/2021
• Patient Sequence Number: 1