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	Material Rupture (1546)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/18/2020
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
Customer reports: the catheter was indwelt on and next day the balloon of catheter was found to be torn in the diaper.The catheter fragmented but was not retained in 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.A decontaminated drainage bag was received for the evaluation.A visual inspection of the sample was carried out according to the procedure, the ruptured catheter with fragments was observed.The component is produced by an external supplier and the assembly process consists in a pick and place operation.There is no additional inspection on the line to detect the condition reported.A production notification was sent to all personnel to ensure that they are aware on the condition reported by the customer.For the corrective actions, we are awaiting to the actions for implement by the supplier.
Additional Manufacturer Narrative
The sample was received by the supplier for investigation.The component was manufactured on january 11, 2019.The device history record was reviewed and found that the product was manufactured according to the established device master record.No deviations were noted on the processing material or parameters.All quality control inspection criteria had been fulfilled satisfactorily.The returned sample was analyzed and confirmed that the balloon burst and was ruptured.The root cause was found to be associated with user misuse as a deterioration point found on the catheter was caused by the use of a petroleum based chemical.The use of petroleum base chemicals during the handling of the catheter can cause rubber properties to become deteriorated and ruptured.This chemical or lubricant may be used by the doctor or nurse during the handling of the product while inserting the catheter into the patient.Corrective actions will be limited to manufacturing awareness.At this time, no further corrective actions are required.

• 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: 10495429
• Report Number: 9612030-2020-02607
• Device Sequence Number: 3593411
• 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): 03/10/2021

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: 1912023964
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 09/04/2020
• Supplement Date Received by Manufacturer: 09/04/2020; 09/04/2020
• Initial Report FDA Received Date: 09/04/2020
• Supplement Report FDA Received Date: 10/22/2020; 03/10/2021
• Patient Sequence Number: 1