MAUDE Adverse Event Report: COVIDIEN PRECISION PRM 16FR CATH SECURE; COLLECTOR, URINE, (AND ACCESSORIES) FOR INDWELLING CATHETER

Model Number	PP16SD
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	05/01/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional information has been requested but to date has not yet been provided.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 a portion of the foley catheter was retained inside of the patients bladder.The foley was inserted by a provider.
Additional Manufacturer Narrative
Submit date: 30-may-2019.Additional incident details were provided by the initial reporter and added.
Additional Manufacturer Narrative
The device history record was reviewed and indicated that the product was released accomplishing all quality standards.One decontaminated incomplete sample was received at the plant for the investigation.The sample received was a of portion of the device and not the complete product.A visual inspection found the sample was cut in half.As a result, we were unable to confirm the reported issue because the body of the catheter was not provided.Because the reported issue could not be confirmed we were unable to determine the root cause.No corrective actions are deemed necessary at this moment.The process is running according to product specifications meeting quality acceptance criteria will be keep monitoring the process for any adverse trends that require immediate attention.

• Brand Name: PRECISION PRM 16FR 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: 8625200
• Report Number: 9612030-2019-02182
• Device Sequence Number: 2387291
• Product Code: KNX
• UDI-Device Identifier: 10884521029699
• UDI-Public: 10884521029699
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/17/2019

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: PP16SD
• Device Catalogue Number: PP16SD
• Device Lot Number: 1904334464
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 05/08/2019
• Supplement Date Received by Manufacturer: 05/08/2019; 05/08/2019
• Initial Report FDA Received Date: 05/20/2019
• Supplement Report FDA Received Date: 05/30/2019; 09/17/2019
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other