MAUDE Adverse Event Report: COVIDIEN PRECISION 400 FLTY16FR WO PVPI; COLLECTOR, URINE, (AND ACCESSORIES) FOR INDWELLING CATHETER

Model Number	7016MF
Medical Device Problem Code	Deflation Problem (1149)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	02/10/2020
Type of Reportable Event	Serious Injury
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.
Event or Problem Description
The customer reported that the balloon inflate was checked before use.When trying to remove the catheter 10 days after it was inserted, only 5ml of water was pulled from the balloon, and the catheter was unable to be removed.The catheter was removed by breaking the balloon by putting 170ml of water in the balloon.The customer further stated that there were fragmented pieces left in the patient that were later removed by cystoscope.
Additional Manufacturer Narrative
Additional information: the following investigation information was received from our supplier: the device history record (dhr) showed the lot produced met all quality requirements and had been sampled accordingly.A sample was received for evaluation.Visual inspection shows the catheter was cut and without the funnel part and half of the shaft.The customer stated they had cut the catheter and burst the balloon for removal from the patient.The reported condition could not be confirmed because the sample received was not in actual form.The exact root cause could not be specifically identified so the investigation was done based on trend analysis.The action plan will be limited to manufacturing awareness.This complaint will be used for tracking and trending purposes.
Additional Manufacturer Narrative
A device history record review could not be performed because a lot number could not be provided by the customer.A sample was evaluated and confirmed the reported condition; the catheter is visibly damaged.The component is produced by an external supplier and the assembly process consists of a pick and place operation at the cardinal health site.There is no additional inspection on the line to detect the condition reported.A production notification was issued to all personnel to heighten awareness of the condition reported by the customer.A supplier notification and response (scar) has been issued to investigate the root cause and corrective actions and is currently pending implementation from the supplier.

• Brand Name: PRECISION 400 FLTY16FR 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: 9807820
• Report Number: 9612030-2020-02432
• Device Sequence Number: 13605439
• Product Code: KNX
• UDI-Device Identifier: 10884521050617
• UDI-Public: 10884521050617
• 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): 06/11/2020

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: 7016MF
• Device Catalogue Number: 7016MF
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 02/26/2020
• Supplement Date Received by Manufacturer: 02/26/2020; 02/26/2020
• Initial Report FDA Received Date: 03/09/2020
• Supplement Report FDA Received Date: 04/20/2020; 06/11/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other