MAUDE Adverse Event Report: COVIDIEN CURITY MONO-FLO 14FR WO PVPI; COLLECTOR, URINE, (AND ACCESSORIES) FOR INDWELLING CATHETER

Model Number	6162MF
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	02/17/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).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 a (b)(6) male patient underwent a hernia surgery on (b)(6) 2020.At 12 pm, the catheter was indwelled and the balloon was checked and performed without problems.At 9 pm, it was found that the catheter had come out on its own.Upon visual inspection of the catheter tip, the balloon seemed to be partially missing and it was assumed there might be fragments of the balloon inside the patient so the doctor confirmed it with a cystoscope.The result was no piece of balloon/catheter was left inside the patient.No patient harm was reported.
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 sample was received for the evaluation.Upon visual evaluation, the reported condition is confirmed.The component is produced by external supplier and the assembly process consists in a pick and place operation.A production notification was sent to all personnel to ensure that they are aware on the condition reported by the customer.The root cause and the corrective actions will be implemented by the supplier.
Additional Manufacturer Narrative
Additional information received from the supplier: the reported condition was confirmed by the supplier, the catheter is visibly damaged.A deterioration point was found on the catheter caused by using a petroleum base chemical.The use of petroleum-based chemicals during the handling of the catheter can cause rubber properties to become deteriorated and rupture.This chemical or lubricant is usually used by the doctor or nurse during handling the product while inserting the catheter into the patient.As the reported condition was not induced by the manufacturing process, further action is not required.A corrective action will be limited to manufacturing awareness.No further corrective action is required at this time.

• Brand Name: CURITY MONO-FLO 14FR WO 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: 9764805
• Report Number: 9612030-2020-02422
• Device Sequence Number: 2587880
• Product Code: KNX
• UDI-Device Identifier: 10884521050587
• UDI-Public: 10884521050587
• 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: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: No Information
• Device Model Number: 6162MF
• Device Catalogue Number: 6162MF
• Device Lot Number: 1918346364
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 02/18/2020
• Supplement Date Received by Manufacturer: 02/18/2020; 02/18/2020
• Initial Report FDA Received Date: 02/27/2020
• Supplement Report FDA Received Date: 04/20/2020; 08/10/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 74 YR