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	Deflation Problem (1149)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/29/2020
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 when attempting to change the catheter, water was unable to be removed from the balloon.The catheter was cut to remove it.There was no harm to the patient.
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.One decontaminated sample was received for the evaluation.Upon visual examination, the catheter shows retention of the liquid.Therefore, the reported condition is confirmed.After evaluating the received sample, an occlusion in the catheter was detected, which causes the liquid retention inhibiting the balloon deflation.The affected component is produced by an external supplier; our assembly process only consists in a pick and place operation for this material.The root cause and the action plans will be implemented by the supplier.
Additional Manufacturer Narrative
An investigation was performed by the supplier.The main root cause of the reported issue occurred due to a residue (black and white particle) floating in the balloon.We suspected that this might cause by excessive threading glue (white particle) and rubber thread residue (black particle).Looking at the size of both particles, the white residue is the one that block the dinking eye.This residue would block the dinking eye, thus cause partial deflation as water could not flow out from balloon.This excessive threading glue usually caused by: dried gum stuck on the threading brush.Currently the threading brush have been subjected to 2 times cleaning per day.Inconsistent amount of gum applied due to various size of threading brush use.The below action plans have been implemented by the supplier: increased the frequency of threading brush cleaning from 2 time per day to 4 times per day.A memo will be provided on this update.Standardize the threading brush size, by controlling only brush size 8 to be use in production floor.This change was implemented.Conduct awareness training to the operator.

• 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: 10649111
• Report Number: 9612030-2020-02653
• Device Sequence Number: 4044244
• 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,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/15/2021

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
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 10/02/2020
• Supplement Date Received by Manufacturer: 10/02/2020; 10/02/2020
• Initial Report FDA Received Date: 10/08/2020
• Supplement Report FDA Received Date: 11/25/2020; 02/15/2021
• Patient Sequence Number: 1