MAUDE Adverse Event Report: COVIDIEN PRECISION PRM 14FR CATH SECURE; COLLECTOR, URINE, (AND ACCESSORIES) FOR INDWELLING CATHETER

Model Number	PP14SD
Medical Device Problem Codes	Break (1069); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/01/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An investigation is currently underway.Upon completion, the results will be forwarded.
Event or Problem Description
The customer reported that the foley was placed on (b)(6) 2020 at 19:15 and broke on (b)(6) 2020 at 19:50 during patient repositioning.The catheter silicone material ripped and had become lacerated when repositioning the patient.There was no patient injury.
Additional Manufacturer Narrative
A device history record could not be reviewed because the lot number was unknown.Four digital images were provided and a decontaminated drainage bag with was received for evaluation.A visual inspection of the sample was performed according to the product specification.The reported issue was observed; the catheter was divided into two parts.The manufacturing process was reviewed by a multifunctional team and determined that the process is running according to product specifications, meeting quality acceptance criteria.The equipment used for the catheter-adapter assembly was verified and found to be up to date for all corrective and preventive maintenance as scheduled.The component is produced by external supplier and the assembly process consists of a pick and place operation at the cardinal health facility.The root cause for the condition was requested from the manufacturer and will be documented through the supplier notification and response form.There is no additional inspection on the line to detect the reported condition.A production notification was issued to all personnel to ensure that they are aware on the condition reported by the customer.We are awaiting an action plan to be implement by the supplier for the corrective actions.The cardinal health facility will continue monitoring the process for any adverse trends that require immediate attention.
Additional Manufacturer Narrative
The root cause for the condition was requested from the manufacturer.The manufacturer attributed the malfunction as the manner in which the device is connected if too much force is used when assembling the device.

• Brand Name: PRECISION PRM 14FR CATH SECURE
• 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: 10543345
• Report Number: 9612030-2020-02615
• Device Sequence Number: 16925003
• Product Code: KNX
• UDI-Device Identifier: 10884521029675
• UDI-Public: 10884521029675
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/01/2021

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: PP14SD
• Device Catalogue Number: PP14SD
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/10/2020
• Initial Date Received by Manufacturer: 09/02/2020
• Supplement Date Received by Manufacturer: 09/02/2020; 09/02/2020
• Initial Report FDA Received Date: 09/16/2020
• Supplement Report FDA Received Date: 10/28/2020; 04/01/2021
• Patient Sequence Number: 1